BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 13516070 · Received February 11, 2022

    Report

    Report Number
    2134265-2022-01083
    Event Type
    Death
    Date Received
    February 11, 2022
    Date of Event
    January 27, 2022
    Report Date
    February 11, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860501
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    USED BSC AWARE DATE AS EVENT DATE IS UNKNOWN.

    Additional Manufacturer Narrative · 0

    USED BSC AWARE DATE AS EVENT DATE IS UNKNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STROKE AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. A FEW HOURS POST-PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND THE PATIENT STAYED IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS LATER REPORTED TO HAVE DIED A FEW WEEKS AFTER THE WATCHMAN IMPLANT PROCEDURE. THE PATIENT REMAINED IN THE ICU FROM TIME OF STROKE UNTIL TIME OF DEATH. NO ADDITIONAL INFORMATION IS KNOWN.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT STROKE AND DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. A FEW HOURS POST-PROCEDURE, THE PATIENT EXPERIENCED A STROKE AND THE PATIENT STAYED IN THE INTENSIVE CARE UNIT (ICU). THE PATIENT WAS LATER REPORTED TO HAVE DIED A FEW WEEKS AFTER THE WATCHMAN IMPLANT PROCEDURE. THE PATIENT REMAINED IN THE ICU FROM TIME OF STROKE UNTIL TIME OF DEATH. NO ADDITIONAL INFORMATION IS KNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1050529 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027805248 08714729860501

    Patients

    Seq Age Sex Outcome Treatment
    1 Male Death