BEUDAMED
    FDA Adverse Event Death Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19134055 · Received April 18, 2024

    Report

    Report Number
    2124215-2024-22402
    Event Type
    Death
    Date Received
    April 18, 2024
    Date of Event
    December 28, 2023
    Report Date
    April 18, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 THE PATIENT EXPERIENCED A STROKE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A WATCHMAN FXD CURVE ACCESS SYSTEM (WAS) AND A 24 MM WATCHMAN FLX PRO LAA CLOSURE DEVICE & DELIVERY SYSTEM (WDS) WERE SELECTED TO BE USED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITH THE CLOSURE DEVICE IMPLANTED IN THE LAA OF THE PATIENT WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 20 MM. THERE WERE NO COMPLICATIONS THAT WERE REPORTED TO HAVE OCCURRED. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE NEXT DAY ON A MEDICATION REGIMEN OF ASPIRIN AND APIXABAN. ON (B)(6) 2023, 37 DAYS POST PROCEDURE THE PATIENT WAS DIAGNOSED WITH ISCHEMIC STROKE. THE PATIENT WAS ON THE MEDICATION REGIMEN OF ASPIRIN AND APIXABAN AT THE TIME OF THE EVENT. THE PATIENT WAS DIAGNOSED WITH LUNG CANCER METASTASIS TO MITRAL VALVE AND MALIGNANT PERICARDIAL EFFUSION. THE ISCHEMIC STROKE WAS SUSPECTED TO BE RELATED TO CANCER EMBOLI FROM MITRAL VALVE LESION. THE PATIENT FOLLOWS UP WITH CARDIOLOGISTS AND WAS SEEN FOR THE TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) POST PROCEDURE. ON (B)(6) 2024, THE PATIENT WAS GIVEN A MRS SCORE OF (MODERATELY SEVERE DISABILITY; UNABLE TO WALK WITHOUT ASSISTANCE AND UNABLE TO ATTEND TO OWN BODILY NEEDS WITHOUT ASSISTANCE). THERE WAS NO FURTHER FOLLOW UP WITH THE PATIENT AT THE WATCHMAN HEAL-LAA STUDY SITE AS THE PATIENT VISITED ANOTHER HOSPITAL. PATIENT STATUS: AN OBITUARY SEARCH WAS COMPLETED ON (B)(6) 2024 BY THE WATCHMAN HEAL-LAA STUDY SITE WHICH REVEALED THE PATIENT PASSED AWAY ON (B)(6) 2024.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2289065 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6024 0032027842 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Male Other| D