BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 12648241 · Received October 18, 2021

    Report

    Report Number
    2134265-2021-13032
    Event Type
    Injury
    Date Received
    October 18, 2021
    Date of Event
    September 27, 2021
    Report Date
    October 18, 2021
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    INITIAL REPORTER FACILITY NAME: (B)(6).

    Description of Event or Problem · 1

    OPTION STUDY. IT WAS REPORTED THAT THE CLOSURE DEVICE DID NOT SEAL. ON (B)(6) 2021, TRANSTHORACIC ECHOCARDIOGRAM (TTE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 60%. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ASSESSMENT REVEALED ONE LEFT ATRIAL APPENDAGE (LAA) LOBE OF CHICKEN WING MORPHOLOGY WITH AN OSTIUM DIAMETER OF 25 MM AND LAA LENGTH OF 35 MM. THE PATIENT UNDERWENT ATRIAL FIBRILLATION (AF) ABLATION USING PULMONARY VEIN ISOLATION BY RADIO FREQUENCY POINT BY POINT METHOD ON (B)(6) 2021. THAT SAME DAY, A 35 MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED SUCCESSFULLY WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 25 MM. AFTER THE IMPLANT, THE PATIENT WAS STARTED ON ASPIRIN. ON (B)(6) 2021, TEN DAYS POST PROCEDURE, THE PATIENT WAS DISCHARGED. ON (B)(6) 2021, 108 DAYS POST ENROLLMENT, DURING THE PROTOCOL SCHEDULED 3-MONTH FOLLOW UP VISIT, TEE REVEALED AN INCOMPLETE LAA SEAL WITH JET SIZE OF GREATER THAN 5 MM. THE SIZE OF LARGEST RESIDUAL JET AROUND DEVICE WAS 8 MM. NO ADDITIONAL INFORMATION IS KNOWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1542528 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0026891009

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Other