AGENT
Report
- Report Number
- 2124215-2025-76554
- Event Type
- Death
- Date Received
- October 24, 2025
- Report Date
- April 21, 2026
- Manufacturer
- BOSTON SCIENTIFIC CORPORATION
- Product Code
- OOB
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
- Health Professional
- N
Narratives
REPORTING QUARTER: Q1 2025. CORRECTION: VESSEL PERFORATION WAS ADDED TO THESE EVENTS PREVIOUSLY REPORTED. TOTAL NUMBER OF PATIENTS ENROLLED THROUGH THE 12 MONTH REPORT MILESTONE: 1919. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. 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). NO NEW RISKS OR INCREASE IN ADVERSE EVENT RATES WERE IDENTIFIED WITH RESPECT TO THE AGENT DCB DEVICE BASED ON THE DATA RECEIVED FROM THE REGISTRY. THERE ARE NO CHANGES IN BENEFIT/RISK OF THE AGENT DCB DEVICE, WITH RESPECT TO COMPLAINTS RESULTING IN SERIOUS INCIDENTS. PER INTERNAL PROCESSES, BSC REGULARLY CONDUCTS CLINICAL TRIAL SAFETY REVIEW (CTSR) MEETINGS TO ASSESS AND DISCUSS CLINICAL DATA INPUTS (INCLUDING, BUT NOT LIMITED TO SAFETY TRIGGER, UADES/USADES, SERIOUS (PUBLIC) HEALTH THREATS, ADVERSE EVENTS, AND DEVICE DEFICIENCIES). THE EVENT DATA ARE ASSESSED FOR ESCALATION AT REGULAR INTERVALS DURING CTSR MEETINGS AND MEASURED AGAINST SAFETY TRIGGERS GENERATED FROM HISTORICAL DATA (AGENT IDE DCB ARM). IMPACTS TO RISK/BENEFIT PROFILE: ADJUNCTIVE DEVICES RISK/BENEFIT PROFILE WILL BE SENT ON A SUPPLEMENTAL REPORT WHEN AVAILABLE. AGENT DCB RISK BENEFIT PROFILE: PUBLICATIONS OF 0-30 DAYS POST-PROCEDURE EVENT RATES FROM THE LITERATURE AND NATIONAL SWEDISH REGISTRY (SCAAR), AS WELL AS SUPPLEMENTAL DATA ON 2ND GENERATION DRUG-ELUTING STENTS (WHERE NO DATA ON AGENT OR COMPETITOR DCB WERE AVAILABLE) HAVE REPORTED RATES OF ALL-CAUSE DEATH FROM 0 - 3.5% (SOURCES: 1,3,5). MYOCARDIAL INFARCTION FROM 0-1.7% (SOURCES: 1,3,5), TVR FROM 0-1.7% (SOURCES: 1,3,5), CARDIAC ARREST FROM 0.2-2% (SOURCES: 1,2,3), ALL BLEEDING FROM 1.1-6.67% (SOURCES: 3,4,6), AND STROKE OF 1.6% (SOURCE: 5). NOTE: THE REPORTED RATES FROM THESE SOURCES OCCURRED FROM 0 TO 30 DAYS POST-PROCEDURE, AS PROCEDURE-ONLY TIMEPOINT DATA HAS NOT BEEN RECORDED IN THE LITERATURE. OVERALL, CLINICAL OUTCOMES THROUGH DISCHARGE FROM THE AGENT PAS TRIAL DATASET ALIGN WITH EXPECTATIONS DERIVED FROM PUBLISHED LITERATURE. THE DISCHARGE EVENT RATES FOUND IN THIS ANALYSIS FOR DEATH (0.8%), MYOCARDIAL INFARCTION (0.2%), TVR (0%), CARDIAC ARREST (1.0%), ALL BLEEDING (0.8%) AND STROKE (0.2%), ARE WITHIN OR LOWER THAN REPORTED RATES FROM ANALYSES OF SIMILAR NATIONAL REGISTRIES, PUBLISHED AGENT AND COMPETITOR DCB LITERATURE, AND THUS ARE IN-LINE WITH PRODUCT PERFORMANCE AND RISK ANALYSIS EXPECTATIONS. CLINICAL DATA SOURCES: CLINICAL TRIALS, REGISTRY DATA, AND LITERATURE 1. SCAAR REGISTRY REPORT 2. CATHPCI REGISTRY (ALL PCI, Q4 2023 TO Q3 2024) 3. AGENT IDE CLINICAL TRIAL 4. AGENT JAPAN SV CLINICAL TRIAL AND ISR SUBSTUDY 5. AGENT ISR CLINICAL TRIAL 6. ZHANG D, SUN Y, LIU X, ET AL. LONG-TERM FOLLOW-UP AFTER TREATMENT OF DRUG-ELUTING STENT RESTENOSIS AND DE NOVO LESIONS USING SEQUENT PLEASE PACLITAXEL-COATED BALLOONS. CLINICAL STUDY. ANGIOLOGY. MAY 2019;70(5):414-422. DOI:10.1177/0003319718809423. UPDATED RISK/BENEFIT PROFILE: PUBLICATIONS OF 0-30 DAYS POST-PROCEDURE EVENT RATES FROM THE LITERATURE AND NATIONAL SWEDISH REGISTRY (SCAAR), AS WELL AS SUPPLEMENTAL DATA ON 2ND GENERATION DRUG-ELUTING STENTS (WHERE NO DATA ON AGENT OR COMPETITOR DCB WERE AVAILABLE) HAVE REPORTED RATES OF ALL-CAUSE DEATH FROM 0 - 3.5%, MYOCARDIAL INFARCTION FROM 0-1.7%, TVR FROM 0-1.7%, CARDIAC ARREST FROM 0.2-2%, ALL BLEEDING FROM 1.1-6.67%, AND STROKE OF 1.6%. NOTE: THE REPORTED RATES FROM THESE SOURCES OCCURRED FROM 0 TO 30 DAYS POST-PROCEDURE, AS PROCEDURE-ONLY TIMEPOINT DATA HAS NOT BEEN RECORDED IN THE LITERATURE. EVENT RATES OBSERVED IN PATIENTS WITH AGENT DCB USE PLUS A BSC ANCILLARY DEVICE(S) WERE COMPARED TO EVENT RATES AVAILABLE IN CLINICAL STUDIES, LITERATURE, AND/OR COMPARABLE REAL-WORLD DATA USING THE PINC AI HEALTHCARE DATABASE (PHD) FOR THE ANCILLARY DEVICE FAMILIES OF APEX (NO DATA AVAILABLE), EMERGE, PROMUS DES, SYNERGY DES, ANGIOJET, AND FILTERWIRE. EVENT RATES OBSERVED IN PATIENTS WITH AGENT DCB USE PLUS A BSC ANCILLARY DEVICE(S) WERE COMPARED TO EVENT RATES AVAILABLE IN COMPARABLE REAL-WORLD DATA USING PHD FOR THE ANCILLARY DEVICE FAMILIES OF NC EMERGE, TRAPPER, WOLVERINE, AND THREADER, AND USING PHD AND SCAAR FOR THE DEVICE FAMILY OF ROTATIONAL ATHERECTOMY. OVERALL, CLINICAL OUTCOMES THROUGH DISCHARGE FROM THE AGENT PAS TRIAL DATASET, PATIENTS WITH AGENT DCB USE PLUS ANCILLARY DEVICE(S), ALIGN WITH EXPECTATIONS OBTAINED FROM THE COMPARATIVE ANALYSIS FOR THE ANCILLARY DEVICE FAMILIES.
REPORTING QUARTER: Q1 2025. CORRECTION: VESSEL PERFORATION WAS ADDED TO THESE EVENTS PREVIOUSLY REPORTED. TOTAL NUMBER OF PATIENTS ENROLLED THROUGH THE 12 MONTH REPORT MILESTONE: 1919. DEVICE EVALUATION: UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, ANONYMIZED DATA WAS PROVIDED. NO PRODUCTS WERE RETURNED AS PART OF THE REGISTRY. 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). NO NEW RISKS OR INCREASE IN ADVERSE EVENT RATES WERE IDENTIFIED WITH RESPECT TO THE AGENT DCB DEVICE BASED ON THE DATA RECEIVED FROM THE REGISTRY. THERE ARE NO CHANGES IN BENEFIT/RISK OF THE AGENT DCB DEVICE, WITH RESPECT TO COMPLAINTS RESULTING IN SERIOUS INCIDENTS. PER INTERNAL PROCESSES, BSC REGULARLY CONDUCTS CLINICAL TRIAL SAFETY REVIEW (CTSR) MEETINGS TO ASSESS AND DISCUSS CLINICAL DATA INPUTS (INCLUDING, BUT NOT LIMITED TO SAFETY TRIGGER, UADES/USADES, SERIOUS (PUBLIC) HEALTH THREATS, ADVERSE EVENTS, AND DEVICE DEFICIENCIES). THE EVENT DATA ARE ASSESSED FOR ESCALATION AT REGULAR INTERVALS DURING CTSR MEETINGS AND MEASURED AGAINST SAFETY TRIGGERS GENERATED FROM HISTORICAL DATA (AGENT IDE DCB ARM). IMPACTS TO RISK/BENEFIT PROFILE: ADJUNCTIVE DEVICES RISK/BENEFIT PROFILE WILL BE SENT ON A SUPPLEMENTAL REPORT WHEN AVAILABLE. AGENT DCB RISK BENEFIT PROFILE: PUBLICATIONS OF 0-30 DAYS POST-PROCEDURE EVENT RATES FROM THE LITERATURE AND NATIONAL SWEDISH REGISTRY (SCAAR), AS WELL AS SUPPLEMENTAL DATA ON 2ND GENERATION DRUG-ELUTING STENTS (WHERE NO DATA ON AGENT OR COMPETITOR DCB WERE AVAILABLE) HAVE REPORTED RATES OF ALL-CAUSE DEATH FROM 0 - 3.5% (SOURCES: 1,3,5). MYOCARDIAL INFARCTION FROM 0-1.7% (SOURCES: 1,3,5), TVR FROM 0-1.7% (SOURCES: 1,3,5), CARDIAC ARREST FROM 0.2-2% (SOURCES: 1,2,3), ALL BLEEDING FROM 1.1-6.67% (SOURCES: 3,4,6), AND STROKE OF 1.6% (SOURCE: 5). NOTE: THE REPORTED RATES FROM THESE SOURCES OCCURRED FROM 0 TO 30 DAYS POST-PROCEDURE, AS PROCEDURE-ONLY TIMEPOINT DATA HAS NOT BEEN RECORDED IN THE LITERATURE. OVERALL, CLINICAL OUTCOMES THROUGH DISCHARGE FROM THE AGENT PAS TRIAL DATASET ALIGN WITH EXPECTATIONS DERIVED FROM PUBLISHED LITERATURE. THE DISCHARGE EVENT RATES FOUND IN THIS ANALYSIS FOR DEATH (0.8%), MYOCARDIAL INFARCTION (0.2%), TVR (0%), CARDIAC ARREST (1.0%), ALL BLEEDING (0.8%) AND STROKE (0.2%), ARE WITHIN OR LOWER THAN REPORTED RATES FROM ANALYSES OF SIMILAR NATIONAL REGISTRIES, PUBLISHED AGENT AND COMPETITOR DCB LITERATURE, AND THUS ARE IN-LINE WITH PRODUCT PERFORMANCE AND RISK ANALYSIS EXPECTATIONS. CLINICAL DATA SOURCES: CLINICAL TRIALS, REGISTRY DATA, AND LITERATURE 1. SCAAR REGISTRY REPORT 2. CATHPCI REGISTRY (ALL PCI, Q4 2023 TO Q3 2024) 3. AGENT IDE CLINICAL TRIAL 4. AGENT JAPAN SV CLINICAL TRIAL AND ISR SUBSTUDY 5. AGENT ISR CLINICAL TRIAL 6. ZHANG D, SUN Y, LIU X, ET AL. LONG-TERM FOLLOW-UP AFTER TREATMENT OF DRUG-ELUTING STENT RESTENOSIS AND DE NOVO LESIONS USING SEQUENT PLEASE PACLITAXEL-COATED BALLOONS. CLINICAL STUDY. ANGIOLOGY. MAY 2019;70(5):414-422. DOI:10.1177/0003319718809423.
THIS REPORT SUMMARIZES 4 DEATH EVENTS. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT AND A SINGLE PATIENT MAY HAVE MULTIPLE DEVICES INVOLVED. OUT OF THE 4 DEATH EVENTS: 4 WERE HEMORRHAGE/BLOOD LOSS/BLEEDING. 4 WERE PERFORATION OF VESSELS. 4 WERE CARDIOGENIC SHOCK. 4 WERE CARDIAC TAMPONADE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE DEVICES REPORTED IN THE CATHPCI REGISTRY. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE REGISTRY DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.
THIS REPORT SUMMARIZES 4 DEATH EVENTS. NOTE THAT MULTIPLE EVENT TERMS MAY APPLY TO A SINGLE PATIENT AND A SINGLE PATIENT MAY HAVE MULTIPLE DEVICES INVOLVED. OUT OF THE 4 DEATH EVENTS: 4 WERE HEMORRHAGE/BLOOD LOSS/BLEEDING. 4 WERE PERFORATION OF VESSELS. 4 WERE CARDIOGENIC SHOCK. 4 WERE CARDIAC TAMPONADE. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR THE DEVICES REPORTED IN THE CATHPCI REGISTRY. PATIENT EVENTS WERE REPORTED AS EVENT TERMS WITH NO FURTHER DETAILED INFORMATION. UNDER THE TERMS AND CONDITIONS OF THE REGISTRY, DATA IS ANONYMIZED BEFORE BEING TRANSMITTED TO BSC, THUS THERE ARE SIGNIFICANT LIMITATIONS TO BSC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED AS A SPONTANEOUS COMPLAINT. THE REGISTRY DOES NOT PROVIDE A CAUSALITY RELATIONSHIP FOR EACH REPORTED EVENT TO THE DEVICE. NO FURTHER INFORMATION IS AVAILABLE TO BSC.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1402372 | AGENT | DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER | OOB | BOSTON SCIENTIFIC CORPORATION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Unknown |