BEUDAMED
    FDA Adverse Event Injury Summary report: Y

    AGENT

    MDR report key: 24148734 · Received January 22, 2026

    Report

    Report Number
    2124215-2026-04122
    Event Type
    Injury
    Date Received
    January 22, 2026
    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: OCTOBER 1, 2025 TO DECEMBER 31, 2025. THIS REPORT SUMMARIZES 754 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, EMERGE, LOX, NC EMERGE, LOX, NC QUANTUM APEX,LOX, ROTABLATOR ROTATIONAL ATHERECTOMY SYSTEM, MCX, ROTAPRO,MCX, SYNERGY MEGATRON, NIQ, SYNERGY XD,NIQ, TAPPER EXCHANGE DEVICE, DQY, WOLVERINE CORONARY CUTTING BALLOON, 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 754 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: 45 PERFORATION OF VESSELS, 185 HEART FAILURE/CONGESTIVE HEART FAILURE, 77 MYOCARDIAL INFARCTION, 108 CARDIOGENIC SHOCK, 83 HEMORRHAGE/BLOOD LOSS/BLEEDING, 88 CARDIAC ARREST, 52 UNSPECIFIED KIDNEY OR URINARY PROBLEM, 90 VASCULAR DISSECTION, 34 NO CLINICAL SIGNS, SYMPTOMS OR CONDITIONS, 28 ISCHEMIA STROKE, 6 STROKE/CVA, 62 HEMATOMA, 28 CARDIAC TAMPONADE, 97 PERFORATION OF VESSELS, 37 ADDITIONAL SURGERY. THESE EVENTS, BASED ON DATA FROM THE ACC CATHPCI REGISTRY, ARE BEING REPORTED AS EVENTS THAT COULD HAVE POTENTIALLY BEEN PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC AND REPORTED AS AN MDR WHEN THE EVENT OCCURRED. BSC REPORTS THE EVENTS IN COMPLIANCE TO 21 CFR 803.3. BECAUSE ACC CATHPCI REGISTRY DATA IS DE-IDENTIFIED BEFORE BEING TRANSMITTED TO BOSTON SCIENTIFIC, THERE ARE SIGNIFICANT LIMITATIONS TO BOSTON SCIENTIFIC'S ABILITY TO CORRELATE THE DATA TO INFORMATION PREVIOUSLY REPORTED TO BOSTON SCIENTIFIC. ADDITIONALLY, EVENT DATE, EVENT OUTCOME , AND INITIAL REPORTER ARE NOT PROVIDED DUE TO THE TERMS OF THE ACC CATHPCI REGISTRY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206940 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Unknown