BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 11784428 · Received May 6, 2021

    Report

    Report Number
    2134265-2021-05595
    Event Type
    Injury
    Date Received
    May 6, 2021
    Date of Event
    February 19, 2021
    Report Date
    May 6, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, PROPHYLACTIC ANTIBIOTICS WERE ADMINISTERED. ASPIRIN WAS ADMINISTERED ONE DAY PRIOR TO THE PROCEDURE AND HEPARIN WAS ADMINISTERED PRE-TRANSSEPTAL PUNCTURE. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 17.3 MM. ON (B)(6) 2020, THE PATIENT WAS DISCHARGED ON ASPIRIN. AT THE 3-MONTH FOLLOW UP VISIT ON (B)(6) 2020, TRANSESOPHAGEAL ECHO (TEE) REVEALED A COMPLETE LAA SEAL, NO THROMBUS ON THE LEFT ATRIUM AND ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. RIVAROXABAN WAS STOPPED ON (B)(6) 2020 AND THE PATIENT CONTINUED ONLY ON ASPIRIN. AT 12-MONTH FOLLOW UP VISIT ON (B)(6) 2021, COMPUTED TOMOGRAPHY (CT) REVEALED A COMPLETE LAA SEAL, NO THROMBUS ON THE LEFT ATRIUM AND ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. ON (B)(6) 2021, 373 DAYS POST INDEX PROCEDURE, THE 12-MONTH FOLLOW UP ECHOCARDIOGRAPHY REVEALED THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN DEVICE. THE THROMBUS WAS LAMINAR IN NATURE AND WAS NON-MOBILE. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    683687 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10393 0024252869

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Other