BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 16014824 · Received December 20, 2022

    Report

    Report Number
    2124215-2022-53424
    Event Type
    Death
    Date Received
    December 20, 2022
    Date of Event
    November 9, 2022
    Report Date
    January 4, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    WATCHMAN PMS. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 24MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2022, 979 DAYS POST INDEX PROCEDURE THE PATIENT DIED OF UNKNOWN CAUSES.

    Description of Event or Problem · 0

    WATCHMAN PMS. IT WAS REPORTED THAT A PATIENT DEATH OCCURRED. IN (B)(6) 2020, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 24MM WATCHMAN LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). IN (B)(6) 2022, 979 DAYS POST INDEX PROCEDURE THE PATIENT DIED OF UNKNOWN CAUSES. IT WAS FURTHER REPORTED THE PATIENT DIED AT HOME DUE TO SUDDEN CARDIAC DEATH. ON AN UNKNOWN DATE POST INDEX PROCEDURE THE PATIENT EXPERIENCED HEART FAILURE AND A CEREBRAL INFARCTION WITH MILD SEQUELAE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2908476 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10365 0023351071

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death