BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 20480998 · Received October 18, 2024

    Report

    Report Number
    2124215-2024-64994
    Event Type
    Death
    Date Received
    October 18, 2024
    Date of Event
    June 21, 2024
    Report Date
    October 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE WATCHMAN HEAL-LAA STUDY ON (B)(6) 2023 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT PATIENT DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN ACCESS SYSTEM (WAS) AND A 24MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WAS IMPLANTED ON (B)(6) 2023, WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON A MEDICATION REGIME OF APIXABAN. ON (B)(6) 2024, 221 DAYS POST INDEX PROCEDURE, THE PATIENT WAS REPORTED TO HAVE PASSED AWAY. NO ADDITIONAL INFORMATION ON THE CAUSE OF DEATH WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1848263 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6024 0031977695 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Male Death