BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 19633367 · Received June 28, 2024

    Report

    Report Number
    2124215-2024-39344
    Event Type
    Injury
    Date Received
    June 28, 2024
    Date of Event
    June 17, 2024
    Report Date
    June 28, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004613
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AR, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE HEAL-LAA STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 31 MM WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 25 MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL THE SAME DAY. ON (B)(6) 2024, 49 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL SCHEDULED 45-DAY FOLLOW UP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING ASSESSMENT WAS PERFORMED WHICH REVEALED A THROMBUS ATTACHED TO THE THREADED INSERT OF THE CLOSURE DEVICE. THE PATIENT MEDICATION REGIME WAS CHANGED FROM ASPIRIN (81MG) AND CLOPIDOGREL (75MG) TO APIXABAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    816057 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6031 0032027844 00191506004613

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Male Other