BEUDAMED
    FDA Adverse Event Death Summary report: N

    AGENT

    MDR report key: 19538837 · Received June 14, 2024

    Report

    Report Number
    2124215-2024-35956
    Event Type
    Death
    Date Received
    June 14, 2024
    Date of Event
    February 2, 2024
    Report Date
    June 14, 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 ALLIANCE REGISTRY. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. ON (B)(6) 2023, AN AGENT DCB MR 3.50 X 20MM WAS SELECTED FOR TREATMENT OF THE 75% STENOSED TARGET LESION. THE PATIENT WAS DISCHARGED WITH NO COMPLICATIONS ON (B)(6) 2023. HOWEVER, ON (B)(6) 2024, THE PATIENT DIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    373743 AGENT DRUG-ELUTING PERCUTANEOUS TRANSLUMINAL CORONARY ANGIOPLASTY CATHETER OOB BOSTON SCIENTIFIC CORPORATION 3825

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Death