BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 11797874 · Received May 10, 2021

    Report

    Report Number
    2134265-2021-05506
    Event Type
    Injury
    Date Received
    May 10, 2021
    Date of Event
    January 15, 2021
    Report Date
    May 10, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE PROCEDURE, PROPHYLACTIC ANTIBIOTICS WERE NOT ADMINISTERED. ASPIRIN WAS NOT STARTED ONE DAY PRIOR TO PROCEDURE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED. A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 17 MM. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED ON ASPIRIN. ON (B)(6) 2021, 93 DAYS POST PROCEDURE, THE 3-MONTH FOLLOW-UP CORE-LAB REPORTED ECHOCARDIOGRAPHY REVEALED THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. THE THROMBUS WAS LAMINAR IN NATURE AND NON-MOBILE. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    692371 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0024818209

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Other