BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    AGENT

    MDR report key: 23404280 · Received October 28, 2025

    Report

    Report Number
    2124215-2025-77080
    Event Type
    Injury
    Date Received
    October 28, 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

    Additional Manufacturer Narrative · 0

    REPORTING QUARTER: JULY 1, 2025 TO SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 528 SERIOUS INJURY EVENTS FOR ALL BSC DEVICES REPORTED IN THE ACC CATHPCI REGISTRY. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. DEVICES REPORTED FOLLOWED BY THE PROCODE: -AGENT, OOB. -APEX FLEX, LOX. -EMERGE, LOX. -NC EMERGE, LOX. -NC QUANTUM APEX, LOX. -ROTAPRO, MCX. -SYNERGY MEGATRON, NIQ. -SYNERGY XD, NIQ. -TAPPER EXCHANGE DEVICE, DQY. -WOLVERINE CORONARY CUTTING BALLON, NWX. 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 ACCF CATHPCI NCDR. 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 TRANSFERRED NCDR 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). 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%1,3,5, MYOCARDIAL INFARCTION FROM 0-1.7%1,3,5, TVR FROM 0-1.7%1,3,5, CARDIAC ARREST FROM 0.2-2%1,2,3, ALL BLEEDING FROM 1.1-6.67%3,4,6, AND STROKE OF 1.6%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 (0.9%), MYOCARDIAL INFARCTION (0.4%), TVR (0.1%), CARDIAC ARREST (1.1%), ALL BLEEDING (1.1%) AND STROKE (0.3%), 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. ADJUNCTIVE DEVICES RISK/BENEFIT PROFILE IS CURRENTLY IN PROGRESS AND WILL BE SENT ON A SUPPLEMENTAL REPORT UPON COMPLETION. 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.

    Additional Manufacturer Narrative · 0

    REPORTING QUARTER: JULY 1, 2025 TO SEPTEMBER 30, 2025. THIS REPORT SUMMARIZES 528 SERIOUS INJURY EVENTS FOR FOR ALL BSC DEVICES REPORTED IN THE ACC CATHPCI REGISTRY. DEVICE RELATIONSHIP TO THE EVENTS REPORTED IS NOT PROVIDED. DEVICES REPORTED FOLLOWED BY THE PROCODE: -AGENT, OOB -APEX FLEX, LOX -EMERGE, LOX -NC EMERGE, LOX -NC QUANTUM APEX, LOX -ROTAPRO, MCX -SYNERGY MEGATRON, NIQ -SYNERGY XD, NIQ -TAPPER EXCHANGE DEVICE, DQY -WOLVERINE CORONARY CUTTING BALLON, NWX. 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 ACCF CATHPCI NCDR. 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 TRANSFERRED NCDR 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). 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%1,3,5, MYOCARDIAL INFARCTION FROM 0-1.7%1,3,5, TVR FROM 0-1.7%1,3,5, CARDIAC ARREST FROM 0.2-2%1,2,3, ALL BLEEDING FROM 1.1-6.67%3,4,6, AND STROKE OF 1.6%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 (0.9%), MYOCARDIAL INFARCTION (0.4%), TVR (0.1%), CARDIAC ARREST (1.1%), ALL BLEEDING (1.1%) AND STROKE (0.3%), 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 ADJUNCTIVE DEVICES RISK/BENEFIT PROFILE IS CURRENTLY IN PROGRESS AND WILL BE SENT ON A SUPPLEMENTAL REPORT UPON COMPLETION. TOTAL NUMBER OF PATIENTS ENROLLED THROUGH MARCH 2025: 7598.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 528 SERIOUS INJURY EVENTS. IT SHOULD BE NOTED THAT SOME PATIENTS WITHIN THIS POPULATION EXPERIENCED MULTIPLE INJURIES. A SUMMARY OF THE TYPE AND COUNT OF SERIOUS INJURY EVENTS INCLUDE: 74 PERFORATIONS OF VESSELS. 108 HEART FAILURE/CONGESTIVE HEART FAILURE. 42 MYOCARDIAL INFARCTIONS. 62 CARDIOGENIC SHOCKS. 83 HEMORRHAGE/BLOOD LOSS/BLEEDING. 60 HEMATOMAS. 55 CARDIAC ARRESTS. 15 UNSPECIFIED KIDNEY OR URINARY PROBLEMS. 73 VASCULAR DISSECTIONS. 24 ISCHEMIA STROKES. 34 ADDITIONAL SURGERIES. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR BSC DEVICES REPORTED IN THE ACC 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.

    Description of Event or Problem · 0

    THIS REPORT SUMMARIZES 528 SERIOUS INJURY EVENTS. IT SHOULD BE NOTED THAT SOME PATIENTS WITHIN THIS POPULATION EXPERIENCED MULTIPLE INJURIES. A SUMMARY OF THE TYPE AND COUNT OF SERIOUS INJURY EVENTS INCLUDE: 74 PERFORATIONS OF VESSELS 108 HEART FAILURE/CONGESTIVE HEART FAILURE 42 MYOCARDIAL INFARCTION 62 CARDIOGENIC SHOCK 83 HEMORRHAGE/BLOOD LOSS/BLEEDING. 60 HEMATOMATA. 55 CARDIAC ARRESTS. 15 UNSPECIFIED KIDNEY OR URINARY PROBLEMS. 73 VASCULAR DISSECTIONS. 24 ISCHEMIA STROKES. 34 ADDITIONAL SURGERIES. BOSTON SCIENTIFIC RECEIVED NOTIFICATION OF EVENTS FOR BSC DEVICES REPORTED IN THE ACC 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
    390757 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1