BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 18963151 · Received March 22, 2024

    Report

    Report Number
    2124215-2024-17540
    Event Type
    Death
    Date Received
    March 22, 2024
    Date of Event
    January 22, 2024
    Report Date
    March 22, 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

    JAPAN AGENT ALLIANCE REGISTRY: IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2023, THE PATIENT WAS REFERRED DUE TO SEVERE AORTIC STENOSIS. AN AGENT DCB MR 3.00 X 20MM WAS SELECTED FOR TREATMENT. THE TARGET LESION WAS LOCATED IN THE RIGHT CORONARY ARTERY (RCA). THE AGENT BALLOON WAS USED TO TREAT THE TARGET LESION WITH NO ISSUES. IN (B)(6) 2024, THE PATIENT EXPERIENCED CARDIAC ARREST AND WAS RUSHED TO THE HOSPITAL FOR EMERGENCY CARE. DURING EMERGENCY CARE, THE PATIENT HAD DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    877756 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Male Death