BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16018818 · Received December 20, 2022

    Report

    Report Number
    2124215-2022-52950
    Event Type
    Death
    Date Received
    December 20, 2022
    Date of Event
    October 10, 2022
    Report Date
    March 24, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: EVENT DESCRIPTION UPDATED.

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2022, 675 DAYS POST INDEX PROCEDURE, THE PATIENT DIED AT HOME OF UNKNOWN CAUSES.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2022, 675 DAYS POST INDEX PROCEDURE THE PATIENT DIED AT HOME OF UNKNOWN CAUSES. IT WAS FURTHER REPORTED THE OFFICIAL CAUSE OF PATIENT DEATH WAS UNRELATED TO THE LAA PROCEDURE OR THE WATCMAN DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447387 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025906647 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Death