BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 21254041 · Received January 28, 2025

    Report

    Report Number
    2124215-2025-02822
    Event Type
    Injury
    Date Received
    January 28, 2025
    Date of Event
    August 6, 2024
    Report Date
    January 28, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    DA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B3 DATE OF EVENT - ARTICLE PUBLISH DATE USED AS EVENT DATE IS UNKNOWN. NIELSEN-KUDSK, J. E., ANDERSEN, A., KRAMER, A., ESKILDSEN, V., TIROKE, L., MOLLER JENSEN, J., ... & KORSHOLM, K. (2024). LEFT ATRIAL APPENDAGE CLOSURE: WHAT IS FABRIC EDGE LEAK AND HOW CAN IT BE TREATED?. CARDIOVASCULAR INTERVENTIONS, 17(19), 2312-2314.

    Description of Event or Problem · 0

    REPORTED VIA JOURNAL ARTICLE: IT WAS REPORTED THAT THE DEVICE DID NOT SEAL. A NOVEL METHOD TO TREAT FABRIC EDGE LEAK BY INTRADEVICE PLUGGING USING A NON-BOSTON SCIENTIFIC PLUG WAS PERFORMED. AMONG MORE THAN 700 CONSECUTIVE WATCHMAN FLX CASES, 7 PATIENTS WERE DIAGNOSED WITH SUBSTANTIAL FABRIC EDGE LEAK FROM ROUTINE FOLLOW-UP CARDIAC COMPUTED TOMOGRAPHY. LEAK CLOSURE WAS PERFORMED IN LOCAL ANALGESIA GUIDED BY INTRACARDIAC ECHOCARDIOGRAPHY FROM THE LEFT ATRIUM AND FLUOROSCOPY. THERE WERE NO COMPLICATIONS. ON COMPUTED TOMOGRAPHY FOLLOW-UP, 4 PATIENTS HAD COMPLETE LEAK CLOSURE, WHEREAS 3 HAD CONTRAST IN THE DISTAL LAA WITHOUT VISIBLE GAPS/LEAKS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2376087 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention