ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM
Report
- Report Number
- 2124215-2025-44117
- Event Type
- Death
- Date Received
- July 2, 2025
- Report Date
- July 18, 2025
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- NIU
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
CORRECTION: REPORT SOURCE OTHER. TIME FRAME OF EVENT DATE COLLECTION: PATIENTS IN TRUVETA HEALTH SYSTEMS WHO RECEIVED AN ELUVIA DEVICE BETWEEN FEBRUARY 5, 2011 AND JUNE 7, 2024. SUMMARY OF ADVERSE EVENTS: 30 DAY MORTALITY; 30 DAY, 90 DAY, 12 MONTH AND 24 MONTH AMPUTATION (BOTH ALL AMPUTATION AND SAME LIMB AMPUTATION), AND 12 AND 24 MONTH TARGET VESSEL REVASCULARIZATION (TVR). TOTAL NUMBER OF ELUVIA PATIENTS: 440. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE STUDY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE STUDY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU). CONTEXTUAL ANALYSIS: LIMITATIONS: THIS WAS AN EXPLORATORY ANALYSIS OF REAL WORLD DATA USING TRUVETA?S ELECTRONIC HEALTH RECORDS DATA INCLUDING FEASIBILITY ASSESSMENT OF A NATURAL LANGUAGE PROCESS MODEL (NLPM) IN EARLY INFANCY. ONLY 10% OF THE HEALTHCARE SYSTEMS PROVIDING DATA CONTRIBUTED TO THE NLPM REINTERVENTION DATA. ONLY PATIENTS WITH UNIQUE DEVICE IDENTIFIER (UDI) CODES WERE INCLUDED IN THIS ANALYSIS AND THEREFORE, IT IS LIKELY THAT NOT ALL USES OF ELUVIA DEVICES ARE CAPTURED. WHILE TRUVETA DATA AS A WHOLE IS NATIONALLY REPRESENTATIVE WHEN COMPARED TO THE US CENSUS, THE POPULATION INCLUDED FOR SPECIFIC STUDIES MAY NOT BE REPRESENTATIVE. FURTHER, DATA ON PATIENTS WHO RECEIVE CARE OUTSIDE OF TRUVETA HEALTH SYSTEMS WOULD NOT BE CAPTURED IN TRUVETA DATA. THE 12-MONTH FREEDOM FROM AMPUTATION RATE (SAME LIMB) WITHIN THE TRUVETA ANALYSIS OF 94.6% ALIGNS WITH EXPECTATIONS DERIVED FROM PUBLISHED LITERATURE WHICH RANGE FROM 92.9%-100% [1-3]. SIMILARLY, THE 12-MONTH TVR RATE OF 3.4% OBSERVED IN THIS ANALYSIS IS LOWER THAN RATES REPORTED IN THE LITERATURE (6.9%) [4]. THE LOWER OBSERVED RATES ARE DUE TO THE LIMITED CONTRIBUTING DATA, MISSING AND/OR INCOMPLETE POST INDEX PROCEDURE INTERVENTION PROGRESS NOTES, AND LANGUAGE LEARNING MODEL STILL IN DEVELOPMENT. IMPORTANTLY, TVR DOES NOT IMPLY THAT THE SAME LESION WAS TREATED DURING THE REINTERVENTION. THE 30-DAY ALL-CAUSE MORTALITY RATE OF 5.7% IS HIGHER THAN RATES REPORTED IN THE LITERATURE (0-2.8%) [4-7], HOWEVER, THIS IS LIKELY DUE TO THE EXCLUSION OF PATIENTS WITH A DOCUMENTED LIFE EXPECTANCY OF LESS THAN 12 MONTHS IN ADDITION TO OTHER INCLUSION/ EXCLUSION CRITERIA THAT MAY LEAD TO A HEALTHIER POPULATION. WHILE HEALTH ANALYTICS PLATFORMS HOLD GREAT PROMISE FOR ADVANCING HEALTHCARE, THERE ARE IMPORTANT LIMITATIONS THAT MUST BE CONSIDERED WHEN INTERPRETING THESE DATA. ELECTRONIC HEALTH RECORD DATA MAY BE MISSING OR INCONSISTENT DUE TO THE VARIED SOURCES, TIMELINESS OF DATA ENTRY, METHODS OF COLLECTION, DIFFERENCES IN NOMENCLATURE BETWEEN EHR PLATFORMS, AND DOCUMENTATION. CODING PRACTICES CAN COMPLICATE THE PROCESS OF INTEGRATING AND HARMONIZING DATA ACROSS MULTIPLE SOURCES. ONLY A SMALL PERCENTAGE OF HEALTH SYSTEMS WERE ACTUALLY PROVIDING UDI DATA AT THE TIME OF THIS DATA QUERY. FINALLY, WE PERFORMED THIS ANALYSIS EARLY IN THE REALM OF ELECTRONIC HEALTH RECORD DATA. SYSTEMS HAVE IMPROVED, DATA HAS BEEN ENRICHED, SUBMISSION OF HEALTH SYSTEM DATA HAS INCREASED, AND GRANULARITY OF THE DATA HAS EVOLVED. REFERENCES 1. KIM, J., ET AL., KOREAN MULTICENTER REGISTRY OF ELUVIA STENT FOR FEMOROPOPLITEAL ARTERY DISEASE: K-ELUVIA REGISTRY. KOREAN CIRC J, 2024. 54(9): P. 565-576. 2. WITTIG, T., ET AL., RANDOMIZED TRIAL COMPARING A STENT-AVOIDING WITH A STENT-PREFERRED STRATEGY IN COMPLEX FEMOROPOPLITEAL LESIONS. JACC CARDIOVASC INTERV, 2024. 17(9): P. 1134-1144. 3. SOGA, Y., ET AL., HIGH-DOSE DRUG-COATED BALLOON VERSUS POLYMER-BASED DRUG-ELUTING STENT FOR FEMOROPOPLITEAL ARTERY DISEASE TREATMENT. J ENDOVASC THER, 2024: P. 15266028241267759. 4. GRAY, W.A., ET AL., A POLYMER-COATED, PACLITAXEL-ELUTING STENT (ELUVIA) VERSUS A POLYMER-FREE, PACLITAXEL-COATED STENT (ZILVER PTX) FOR ENDOVASCULAR FEMOROPOPLITEAL INTERVENTION (IMPERIAL): A RANDOMISED, NON-INFERIORITY TRIAL. LANCET, 2018. 392(10157): P. 1541-1551. 5. MULLER-HULSBECK, S., ET AL., TWELVE-MONTH RESULTS FROM THE MAJESTIC TRIAL OF THE ELUVIA PACLITAXEL-ELUTING STENT FOR TREATMENT OF OBSTRUCTIVE FEMOROPOPLITEAL DISEASE. J ENDOVASC THER, 2016. 23(5): P. 701-7. 6. GIANNOPOULOS, S., ET AL., CONCOMITANT DRUG-COATED BALLOON ANGIOPLASTY WITH BAIL-OUT USE OF ELUVIA DRUG-ELUTING STENT: IS THERE ANY DOWNSIDE TO A DOUBLE DOSE OF PACLITAXEL? J INVASIVE CARDIOL, 2022. 34(6): P. E469-E476. 7. LANSINK, W. REAL WORLD ALL COMERS DATA FROM THE REGAL REGISTRY ? 2-YEAR RESULTS [POWERPOINT SLIDES] LEIZPIG INTERVENTIONAL COURSE 2023. 6 JUNE 2023. LINC_2023_PROGRAMME.PDF.
TIME FRAME OF EVENT DATE COLLECTION: PATIENTS IN TRUVETA HEALTH SYSTEMS WHO RECEIVED AN ELUVIA DEVICE BETWEEN FEBRUARY 5, 2011 AND JUNE 7, 2024. SUMMARY OF ADVERSE EVENTS: 30 DAY MORTALITY; 30 DAY, 90 DAY, 12 MONTH AND 24 MONTH AMPUTATION (BOTH ALL AMPUTATION AND SAME LIMB AMPUTATION), AND 12 AND 24 MONTH TARGET VESSEL REVASCULARIZATION (TVR). TOTAL NUMBER OF ELUVIA PATIENTS: 440. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE STUDY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE STUDY. IT CANNOT BE DETERMINED IF THESE EVENTS HAVE BEEN PREVIOUSLY REPORTED OR IF THE DEVICES WERE RETURNED FOR ANALYSIS AS PART OF A PREVIOUSLY REPORTED SPONTANEOUS COMPLAINT. HOWEVER, THE EVENTS REPORTED WERE ANTICIPATED IN NATURE AS DEFINED BY THE "POTENTIAL ADVERSE EVENTS" LIST IN THE FDA-APPROVED INSTRUCTIONS FOR USE (IFU). CONTEXTUAL ANALYSIS: THE 12-MONTH FREEDOM FROM AMPUTATION RATE (SAME LIMB) WITHIN THE TRUVETA ANALYSIS OF 94.6% ALIGNS WITH EXPECTATIONS DERIVED FROM PUBLISHED LITERATURE WHICH RANGE FROM 92.9%-100%. SIMILARLY, THE 12-MONTH TVR RATE OF 3.4% OBSERVED IN THIS ANALYSIS IS LOWER THAN RATES REPORTED IN THE LITERATURE (6.9%). THE 30-DAY ALL-CAUSE MORTALITY RATE OF 5.7% IS HIGHER THAN RATES REPORTED IN THE LITERATURE (0-2.8%), HOWEVER, THIS IS LIKELY DUE TO THE EXCLUSION OF PATIENTS WITH A DOCUMENTED LIFE EXPECTANCY OF LESS THAN 12 MONTHS OR GREATER IN THE REFERENCED STUDIES IN ADDITION TO OTHER INCLUSION/ EXCLUSION CRITERIA THAT MAY LEAD TO A HEALTHIER POPULATION. IMPORTANTLY, WHEN COMPARED TO THE TRUVETA BMS CONTROL ARM, THERE WAS NO DIFFERENCE IN EVENT RATES BETWEEN THE TWO GROUPS FOR ANY OF THE AFOREMENTIONED ADVERSE EVENTS.
THIS REPORT SUMMARIZES 25 REPORTED INCIDENTS FOR PATIENT DEATHS WITHIN 30 DAYS POST INDEX PROCEDURE. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. THE ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. PATIENT DEATHS WERE REPORTED WITHIN 30 DAYS FOLLOWING THE INDEX PROCEDURE. 72.5% OF PATIENTS WERE OVER THE AGE OF 65 YEARS. 39.7% OF PATIENTS WERE FEMALE. TYPE OF PROCEDURE: TREATMENT OF PERIPHERAL ARTERIAL DISEASE (PAD). BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE DATA ANALYSIS USING THE AGGREGATE ELECTRONIC HEALTH RECORD DATABASE FROM TRUVETA. THIS ANALYSIS AIMED TO EVALUATE ADVERSE EVENT RATES RELATED TO THE ELUVIA? DRUG-ELUTING VASCULAR STENT SYSTEM DEVICE IN REAL-WORLD USE. THE IMPLANT PROCEDURES WERE PERFORMED FROM (B)(6) 2011 TO (B)(6) 2024. PATIENT EVENTS WERE IDENTIFIED AS EVENT TERMS WITH RATES. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC. WITHIN THIS ANALYSIS, THE TOTAL PATIENT POPULATION SIZE WAS 440 INDIVIDUALS TREATED WITH ELUVIA AND 2785 INDIVIDUALS TREATED WITH BARE METAL STENTS.
Unique Complaint ID Number,Event Date,Date Entered,Manufacturer Aware Date,Brand Name,Generic Name,Model Number,Lot Number,Catalog Number,Serial Number,UDI Number,PMA / 510K Number,Date Returned to Manufacturer,Type of Reportable Event,Event Description,Manufacturer Narrative,Medical History,Patient Age,Patient Gender,Patient Weight,Date Implanted,Date Explanted,Health Effect Clinical Code,Health Effect Impact Code,Device Problem Code,Device Component Code,Investigation Type Code,Investigation Findings Code,Investigation Conclusion Code,Remedial Action Type,Latest Line Item Version;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;19985499,,7/2/2025,4/4/2025,ELUVIATM Drug-Eluting Vascular Stent System,,,,,,,,,D,"This report summarizes 25 reported incidents for patient deaths within 30 days post index procedure. Note that multiple event terms may apply to a single patient but are captured separately under reporting guidelines. Device relationship to the events reported is not provided. ;;The ELUVIA Drug-Eluting Vascular Stent System was selected for use. Patient deaths were reported within 30 days following the index procedure. ;;72.5% of patients were over the age of 65 years. ;39.7% of patients were female;;Type of Procedure: Treatment of peripheral arterial disease (PAD).;;Boston Scientific performed a retrospective data analysis using the aggregate electronic health record database from Truveta. This analysis aimed to evaluate adverse event rates related to the ELUVIA¿ Drug-Eluting Vascular Stent System device in real-world use. The implant procedures were performed from February 2011 to June 2024. Patient events were identified as event terms with rates. Multiple event terms may apply to a single patient. Data obtained from Truveta for this study is de-identified before being accessed by Boston Scientific, thus there are significant limitations to our ability to correlate the data to information previously reported as a spontaneous complaint. The study data does not provide a causality relationship for each reported event to the device. No further information is available to BSC. Within this analysis, the total patient population size was 440 individuals treated with Eluvia and 2785 individuals treated with bare metal stents.","Time Frame of Event Date Collection: Patients in Truveta health systems who received an ELUVIA device between February 5, 2011 and June 7, 2024. ;Summary of Adverse Events: 30 day mortality; 30 day, 90 day, 12 month and 24 month amputation (both all amputation and same limb amputation), and 12 and 24 month target vessel revascularization (TVR). ;Total number of ELUVIA patients: 440;Device Evaluation: Under the terms and conditions of the study, anonymized data was provided. No products were returned as part of the study. It cannot be determined if these events have been previously reported or if the devices were returned for analysis as part of a previously reported spontaneous complaint. However, the events reported were anticipated in nature as defined by the ""Potential Adverse Events"" list in the FDA-approved Instructions for Use (IFU). ;Contextual Analysis: ;Limitations: this was an exploratory analysis of real world data using Truveta¿s electronic health records data including feasibility assessment of a natural language process model (NLPM) in early infancy. Only 10% of the healthcare systems providing data contributed to the NLPM reintervention data. Only patients with unique device identifier (UDI) codes were included in this analysis and therefore, it is likely that not all uses of ELUVIA devices are captured. While Truveta data as a whole is nationally representative when compared to the US Census, the population included for specific studies may not be representative. Further, data on patients who receive care outside of Truveta health systems would not be captured in Truveta data.;The 12-month freedom from amputation rate (same limb) within the Truveta analysis of 94.6% aligns with expectations derived from published literature which range from 92.9%-100% [1-3]. ;Similarly, the 12-month TVR rate of 3.4% observed in this analysis is lower than rates reported in the literature (6.9%) [4]. The lower observed rates are due to the limited contributing data, missing and/or incomplete post index procedure intervention progress notes, and language learning model still in development. Importantly, TVR does not imply that the same lesion was treated during the reintervention. ;The 30-day all-cause mortality rate of 5.7% is higher than rates reported in the literature (0-2.8%) [4-7], however, this is likely due to the exclusion of patients with a documented life expectancy of less than 12 months in addition to other inclusion/ exclusion criteria that may lead to a healthier population. ;While health analytics platforms hold great promise for advancing healthcare, there are important limitations that must be considered when interpreting these data. Electronic health record data may be missing or inconsistent due to the varied sources, timeliness of data entry, methods of collection, differences in nomenclature between EHR platforms, and documentation. Coding practices can complicate the process of integrating and harmonizing data across multiple sources. Only a small percentage of health systems were actually providing UDI data at the time of this data query. Finally, we performed this analysis early in the realm of electronic health record data. Systems have improved, data has been enriched, submission of health system data has increased, and granularity of the data has evolved.;REFERENCES;1. Kim, J., et al., Korean Multicenter Registry of ELUVIA Stent for Femoropopliteal Artery Disease: K-ELUVIA Registry. Korean Circ J, 2024. 54(9): p. 565-576.;2. Wittig, T., et al., Randomized Trial Comparing a Stent-Avoiding With a Stent-Preferred Strategy in Complex Femoropopliteal Lesions. JACC Cardiovasc Interv, 2024. 17(9): p. 1134-1144.;3. Soga, Y., et al., High-Dose Drug-Coated Balloon Versus Polymer-Based Drug-Eluting Stent for Femoropopliteal Artery Disease Treatment. J Endovasc Ther, 2024: p. 15266028241267759.;4. Gray, W.A., et al., A polymer-coated, paclitaxel-eluting stent (Eluvia) versus a polymer-free, paclitaxel-coated stent (Zilver PTX) for endovascular femoropopliteal intervention (IMPERIAL): a randomised, non-inferiority trial. Lancet, 2018. 392(10157): p. 1541-1551.;5. Muller-Hulsbeck, S., et al., Twelve-Month Results From the MAJESTIC Trial of the Eluvia Paclitaxel-Eluting Stent for Treatment of Obstructive Femoropopliteal Disease. J Endovasc Ther, 2016. 23(5): p. 701-7.;6. Giannopoulos, S., et al., Concomitant Drug-Coated Balloon Angioplasty With Bail-Out Use of Eluvia Drug-Eluting Stent: Is There Any Downside to a Double Dose of Paclitaxel? J Invasive Cardiol, 2022. 34(6): p. E469-E476.;7. Lansink, W. Real world all comers data from the REGAL registry ¿ 2-year results [PowerPoint Slides] Leizpig Interventional Course 2023. 6 June 2023. LINC_2023_programme.pdf",peripheral arterial disease (PAD) ,72.5% of patients were over the age of 65 years. ,,,,,E2403,F02,A24,G07001,B17,C19,D12,No,1;
THIS REPORT SUMMARIZES 25 REPORTED INCIDENTS FOR PATIENT DEATHS WITHIN 30 DAYS POST INDEX PROCEDURE. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT BUT ARE CAPTURED SEPARATELY UNDER REPORTING GUIDELINES. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. THE ELUVIA DRUG-ELUTING VASCULAR STENT SYSTEM WAS SELECTED FOR USE. PATIENT DEATHS WERE REPORTED WITHIN 30 DAYS FOLLOWING THE INDEX PROCEDURE. 72.5% OF PATIENTS WERE OVER THE AGE OF 65 YEARS. 39.7% OF PATIENTS WERE FEMALE. TYPE OF PROCEDURE: TREATMENT OF PERIPHERAL ARTERIAL DISEASE (PAD). BOSTON SCIENTIFIC PERFORMED A RETROSPECTIVE DATA ANALYSIS USING THE AGGREGATE ELECTRONIC HEALTH RECORD DATABASE FROM TRUVETA. THIS ANALYSIS AIMED TO EVALUATE ADVERSE EVENT RATES RELATED TO THE ELUVIA? DRUG-ELUTING VASCULAR STENT SYSTEM DEVICE IN REAL-WORLD USE. THE IMPLANT PROCEDURES WERE PERFORMED FROM FEBRUARY 2011 TO JUNE 2024. PATIENT EVENTS WERE IDENTIFIED AS EVENT TERMS WITH RATES. MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT. DATA OBTAINED FROM TRUVETA FOR THIS STUDY IS DE-IDENTIFIED BEFORE BEING ACCESSED BY BOSTON SCIENTIFIC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO OUR ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE STUDY DATA DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC. WITHIN THIS ANALYSIS, THE TOTAL PATIENT POPULATION SIZE WAS 440 INDIVIDUALS TREATED WITH ELUVIA AND 2785 INDIVIDUALS TREATED WITH BARE METAL STENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 152466 | ELUVIATM DRUG-ELUTING VASCULAR STENT SYSTEM | STENT, SUPERFICIAL FEMORAL ARTERY, DRUG-ELUTING | NIU | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown |