BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 18304343 · Received December 11, 2023

    Report

    Report Number
    2124215-2023-69618
    Event Type
    Injury
    Date Received
    December 11, 2023
    Date of Event
    October 20, 2023
    Report Date
    December 11, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860495
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED. COMPUTED TOMOGRAPHY (CT) WAS PERFORMED FORTY-THREE (43) DAYS POST PROCEDURE WHEN THE PATIENT WAS ADMITTED WITH COVID. THE PATIENT DID NOT TAKE HER SIX WEEKS OF ORAL ANTICOAGULATION (OAC) DUE TO HER ILLNESS WITH COVID. THE CT SHOWED A PEDUNCULATED THROMBUS ON THE FACE OF THE THREADED INSERT OF THE CLOSURE DEVICE WHICH WAS BIASED TOWARDS THE LIMBUS. THERE WAS A SMALL SHOULDER WITH A SMALL GUTTER ON THE LIMBUS SIDE OF THE CLOSURE DEVICE. THE PATIENT WAS THEN PLACED ON OAC THERAPY FOR 6 WEEKS. THE PATIENT RETURNED FOR A FOLLOW UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING, WHICH SHOWED THAT THE CLOT HAD APPEARED TO HAVE SHRUNK IN SIZE. THE PATIENT WAS TO CONTINUE OACS FOR APPROXIMATELY THREE MORE WEEKS TO DISSOLVE THE REMAINING THROMBUS AND THEN PERFORM A REPEAT CT. NO FURTHER PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1214115 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0031385898 08714729860495

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Other