BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 19726300 · Received July 11, 2024

    Report

    Report Number
    2124215-2024-43061
    Event Type
    Death
    Date Received
    July 11, 2024
    Date of Event
    April 22, 2024
    Report Date
    July 11, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    OOB
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    ALLIANCE REGISTRY. IT WAS REPORTED THAT THE PATIENT DIED. AN IMPLANTABLE CARDIAC MONITOR PATIENT PRESENTED WITH AN EJECTION FRACTION OF ABOUT 30%. PERCUTANEOUS CORONARY INTERVENTION WAS PERFORMED (B)(6) 2023. TREATMENT WITH 2.00 MM AND 2.50 MM AGENT DCB DEVICES OCCURRED ON (B)(6) 2023 AND THE PATIENT WAS DISCHARGED THE SAME DAY. PULMONARY VEIN ISOLATION WAS THEN PERFORMED FOR PERSISTENT ATRIAL FIBRILLATION ON (B)(6) 2024. THE PATIENT WAS DISCHARGED 5 DAYS LATER. AFTER BEING DISCHARGED FROM THE HOSPITAL, THE PATIENT'S ACTIVITIES OF DAILY LIVING DECREASED AND HOME VISIT TREATMENT BEGAN (B)(6) 2024. ON (B)(6) 2024, THE PATIENT WAS FOUND IN CARDIAC ARREST AND AN AMBULANCE WAS CALLED. THE PATIENT WAS RESUSCITATED, BUT UNRESPONSIVE. THE VISITING PHYSICIAN AND FAMILY DECIDED NOT TO RESUSCITATE FURTHER AND THE PATIENT WAS CONFIRMED DEAD. THE PATIENT WAS DIAGNOSED WITH ACUTE EXACERBATION OF CHRONIC HEART FAILURE BASED ON THE COURSE OF THE DISEASE, ALTHOUGH CARDIAC DEATH WAS CONSIDERED A POSSIBILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2380069 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Male Death