BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 15873043 · Received November 28, 2022

    Report

    Report Number
    2124215-2022-49427
    Event Type
    Injury
    Date Received
    November 28, 2022
    Date of Event
    November 10, 2022
    Report Date
    March 16, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    CHAMPION-AF STUDY: IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 28.0 MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, 120 DAYS POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHO (TEE) REVEALED ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 55 % AND INCOMPLETE LAA SEAL (JET SIZE LESS THAN OR EQUAL TO 5MM) WITH LARGEST RESIDUAL JET AROUND THE DEVICE OF 2 MM WITH PEDUNCULATED, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 1.3 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. IMPLANT TEE ASSESSMENT REVEALED NO EVIDENCE OF INTRACARDIAC THROMBUS, LEFT ATRIAL APPENDAGE THROMBUS AND COMPLEX ATHEROMA. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). EDOXABAN (60 MG) WAS STARTED IN RESPONSE TO DEVICE THROMBUS AND THE PATIENT WAS SCHEDULED FOR A CONTROL TEE IN THREE MONTHS.

    Description of Event or Problem · 0

    CHAMPION-AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 35MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 28.0 MM. ON (B)(6) 2022 THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022 120 DAYS POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHO (TEE) REVEALED ESTIMATED LEFT VENTRICULAR EJECTION FRACTION OF 55 % AND INCOMPLETE LAA SEAL (JET SIZE LESS THAN OR EQUAL TO 5MM) WITH LARGEST RESIDUAL JET AROUND THE DEVICE OF 2 MM WITH PEDUNCULATED, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 1.3 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. IMPLANT TEE ASSESSMENT REVEALED NO EVIDENCE OF INTRACARDIAC THROMBUS, LEFT ATRIAL APPENDAGE THROMBUS AND COMPLEX ATHEROMA. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). EDOXABAN (60 MG) WAS STARTED IN RESPONSE TO DEVICE THROMBUS AND THE PATIENT WAS SCHEDULED FOR A CONTROL TEE IN THREE MONTHS. IT WAS FURTHER REPORTED THAT PRIOR TO INDEX PROCEDURE, ASPIRIN (500MG) AND CLOPIDOGREL (450MG) WERE ADMINISTERED. ON (B)(6) 2022 120 DAYS POST INDEX PROCEDURE, THE PATIENT WAS ON ASPIRIN (100 MG). ON (B)(6) 2023 THE OUTCOME OF THE EVENT WAS CONSIDERED TO BE RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2527303 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0025704315

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Female Other