BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 15855977 · Received November 23, 2022

    Report

    Report Number
    2124215-2022-48840
    Event Type
    Injury
    Date Received
    November 23, 2022
    Date of Event
    November 16, 2022
    Report Date
    February 20, 2023
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CH
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: UPDATED.

    Description of Event or Problem · 0

    CHAMPION-AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (100 MG) AND DABIGATRAN (220 MG) WERE ADMINISTERED. 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 30.4 MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND DABIGATRAN (220 MG). ON (B)(6) 2022, 89 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHO (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 53% AND A COMPLETE SEAL WITH A LAMINAR, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 3.8 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND A 3.8 CM2 NON-MOBILE THROMBUS IN THE LEFT ATRIUM. IMPLANT TEE ASSESSMENT REVEALED NO EVIDENCE OF INTRACARDIAC THROMBUS, LEFT ATRIAL APPENDAGE THROMBUS AND COMPLEX AORTIC ATHEROMA. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN (100 MG). ON (B)(6) 2022, THE PATIENT WAS STARTED ON DABIGATRAN (220 MG) IN RESPONSE TO THE EVENT.

    Description of Event or Problem · 0

    CHAMPION-AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO THE INDEX PROCEDURE, ASPIRIN (100 MG) AND DABIGATRAN (220 MG) WERE ADMINISTERED. 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 30.4 MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND DABIGATRAN (220 MG). ON (B)(6) 2022, 89 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL REQUIRED 4-MONTH LAA-IMAGING AND TRANSESOPHAGEAL ECHO (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 53% AND A COMPLETE SEAL WITH A LAMINAR, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 3.8 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE AND A 3.8 CM2 NON-MOBILE THROMBUS IN THE LEFT ATRIUM. IMPLANT TEE ASSESSMENT REVEALED NO EVIDENCE OF INTRACARDIAC THROMBUS, LEFT ATRIAL APPENDAGE THROMBUS AND COMPLEX AORTIC ATHEROMA. AT THE TIME OF EVENT, THE PATIENT WAS ON ASPIRIN (100 MG). ON (B)(6)2022, THE PATIENT WAS STARTED ON DABIGATRAN (220 MG) IN RESPONSE TO THE EVENT. IT WAS FURTHER REPORTED THAT THE EVENT WAS CONSIDERED TO BE RESOLVED ON (B)(6) 2023 AND DABIGATRAN (220 MG) WAS STOPPED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355116 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027495325

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Male Other