BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 10906534 · Received November 25, 2020

    Report

    Report Number
    2134265-2020-16166
    Event Type
    Injury
    Date Received
    November 25, 2020
    Date of Event
    November 4, 2020
    Report Date
    November 25, 2020
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    (B)(6) STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE PROCEDURE, 300 MG ASPIRIN AND 20 MG RIVAROXABAN WERE ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22MM. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. POST IMPLANT ECHOCARDIOGRAPHY DATED (B)(6) 2020 REVEALED COMPLETE SEAL WITH NO EVIDENCE OF PERICARDIAL EFFUSION AND ATRIAL SEPTAL SHUNT. ON (B)(6) 2020, 49 DAYS POST PROCEDURE, THE PATIENT PRESENTED FOR THE 45-DAY FOLLOW-UP VISIT AND A TEE WAS PERFORMED. THE TEE REVEALED A JET SIZE OF 4 MM AND PRESENCE OF A 0.16 CM SQUARED LAMINAR, NON-MOBILE THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. ON (B)(6) 2020, ASPIRIN AND CLOPIDOGREL WAS STOPPED AND FRAGMIN/DALTEPERIN WAS STARTED IN RESPONSE TO THE EVENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1371862 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025576119

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR Other