BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 15755190 · Received November 8, 2022

    Report

    Report Number
    2124215-2022-45730
    Event Type
    Injury
    Date Received
    November 8, 2022
    Date of Event
    October 28, 2022
    Report Date
    November 8, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860488
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHAMPION AF STUDY: IT WAS REPORTED THAT PERICARDITIS OCCURRED. PRIOR TO THE INDEX PROCEDURE ASPIRIN (81MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY COMPLETED USING A 20MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) WITH A COMPLETE SEAL AND DEPLOYED DEVICE DIAMETER OF 18MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (81 MG), RIVAROXABAN (20 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, 24 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT. ELECTROCARDIOGRAM SHOWED DIFFUSE ST ELEVATION CONSISTENT WITH ACUTE PERICARDITIS, HOWEVER TROPONIN VALUE WAS NEGATIVE. CHEST RADIOGRAPHS REVEALED CHRONIC INTERSTITIAL DISEASE AND LEFT BASILAR ATELECTASIS. THE PATIENT WAS ADMITTED AND ADMINISTERED COLCHICINE. ONE DAY POST HOSPITALIZATION THE PATIENT WAS DISCHARGED ON RIVAROXABAN AND CLOPIDOGREL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2178778 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0029153932 08714729860488

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Hospitalization| O