BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM

    MDR report key: 10886423 · Received November 23, 2020

    Report

    Report Number
    2134265-2020-16179
    Event Type
    Death
    Date Received
    November 23, 2020
    Date of Event
    October 16, 2020
    Report Date
    December 9, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2020 THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. UPON ARRIVAL TO THE HOSPITAL, THE PATIENT HAD 10% HEART FUNCTION, 10% KIDNEY FUNCTION AND HIS BLOOD PRESSURE WAS 74/54MMHG. THE PATIENT DIED ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN. IT WAS FURTHER REPORTED THAT THE PATIENT WAS TAKEN TO THE HOSPITAL AND ADMITTED FOR RENAL PROBLEMS. AN ECHOCARDIOGRAM WAS PERFORMED IN THE ER AT THE HOSPITAL. THE CHEST X-RAY SHOWED THAT THE WATCHMAN WAS STILL IN THE LAA.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A DEATH OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A WATCHMAN LAA CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS DISCHARGED THE FOLLOWING DAY. ON (B)(6) 2020 THE PATIENT WAS TAKEN TO THE HOSPITAL VIA AMBULANCE. UPON ARRIVAL TO THE HOSPITAL, THE PATIENT HAD 10% HEART FUNCTION, 10% KIDNEY FUNCTION AND HIS BLOOD PRESSURE WAS 74/54MMHG. THE PATIENT DIED ON (B)(6) 2020. THE CAUSE OF DEATH IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1353568 WATCHMAN LAA CLOSURE DEVICE & DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Death