BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 15374325 · Received September 7, 2022

    Report

    Report Number
    2124215-2022-33571
    Event Type
    Injury
    Date Received
    September 7, 2022
    Date of Event
    August 24, 2022
    Report Date
    September 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(6).

    Description of Event or Problem · 0

    CHAMPION AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS SUCCESSFULLY PERFORMED USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS) AND A WATCHMAN ACCESS SYSTEM (WAS) WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 27.6 MM. THE FOLLOWING DAY THE PATIENT WAS DISCHARGED ON ASPIRIN 100MG AND DABIGATRAN 220MG. ON (B)(6) 2022, 124 DAYS POST PROCEDURE, DURING A ROUTINE FOLLOW UP EXAMINATION TRANSESOPHAGEAL ECHOCARDIOGRAM IMAGING REVEALED A LAMINAR, NON MOBILE THROMBUS MEASURING 0.8CM SQUARED ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. A SECOND NON MOBILE THROMBUS MEASURING 0.8CM SQUARED WAS ALSO VISUALIZED IN THE LEFT ATRIUM. IN RESPONSE TO THE THROMBUS A MEDICATION ADJUSTMENT WAS MADE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2122727 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027497803

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other