BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 16710025 · Received April 10, 2023

    Report

    Report Number
    2124215-2023-15735
    Event Type
    Injury
    Date Received
    April 10, 2023
    Date of Event
    March 1, 2023
    Report Date
    April 10, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    LITERATURE CITATION: BASHARAT S, CHATTA P, CHUNG J, ET AL. LEFT ATRIAL APPENDAGE OCCLUSIVE DEVICES AS NIDUS FOR THROMBUS FORMATION.. J AM COLL CARDIOL. 2023 MAR, 81 (8_SUPPLEMENT) 3857. HTTPS://DOI.ORG/10.1016/S0735-1097(23)04301-2. DATE OF EVENT- ESTIMATED BASED ON TIMELINE IN LITERATURE ARTICLE. IMPLANT DATE - ESTIMATED BASED ON TIMELINE IN LITERATURE ARTICLE.

    Description of Event or Problem · 0

    IT WAS REPORTED VIA LITERATURE THAT A THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MMWATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) PERFORMED 45 DAYS POST INDEX PROCEDURE WHILE THE PATIENT WAS STILL ON APIXABAN SHOWED A LARGE THROMBOSIS (2.4 X 0.9CM) WITH MOBILE COMPONENTS NOTED. THE PATIENT WAS TREATED WITH INTRAVENOUS HEPARIN AND DISCHARGED ON DABIGATRAN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1869002 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Female Required Intervention