BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18943910 · Received March 20, 2024

    Report

    Report Number
    2124215-2024-15884
    Event Type
    Injury
    Date Received
    March 20, 2024
    Date of Event
    October 23, 2023
    Report Date
    March 20, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OPTION STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE CLOSURE PROCEDURE WAS PERFORMED, AND A 31MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND A DEPLOYED DEVICE DIAMETER OF 24.3 MM. AFTER THE IMPLANT THE PATIENT WAS CONTINUED ON ASPIRIN, WARFARIN/VKA, AND CLOPIDOGREL. THE PATIENT WAS DISCHARGED THE SAME DAY. ON (B)(6) 2023, 854 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE HOSPITAL WITH THE COMPLAINT OF DIFFICULTY IN SPEAKING FOR ONE HOUR WHICH WAS EARLIER IN THE DAY. AT THE TIME OF ADMISSION TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT, SPEECH WAS BACK TO NORMAL. THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL MEDICATION REGIMEN. COMPUTED TOMOGRAPHY (CT) OF HEAD AND NECK WAS PERFORMED WHICH WAS NORMAL AND NEUROLOGY WAS CONSULTED. ON (B)(6) 2023, THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION AND TREATMENT. THE NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) SCORE WAS 1 FROM A BASELINE OF 0. A TRANSTHORACIC ECHOCARDIOGRAM (TTE) WAS PERFORMED WHICH REVEALED COMPLETE SEAL OF THE WATCHMAN FLX CLOSURE DEVICE WITHIN THE LEFT ATRIAL APPENDAGE (LAA) AND NO THROMBUS ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE PATIENT WAS DIAGNOSED WITH A TIA AND STOPPED ON ASPIRIN AND STARTED ON APIXABAN MEDICATION. THE EVENT WAS CONSIDERED RESOLVED AND THE PATIENT WAS DISCHARGED HOME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    436787 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027121301 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Male Other| H