BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 15695217 · Received October 29, 2022

    Report

    Report Number
    2124215-2022-44268
    Event Type
    Injury
    Date Received
    October 29, 2022
    Date of Event
    October 14, 2022
    Report Date
    August 18, 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

    Additional Manufacturer Narrative · 0

    B5 UPDATED WITH ADDITIONAL INFORMATION.

    Additional Manufacturer Narrative · 0

    B5 CORRECTED

    Description of Event or Problem · 0

    CHAMPION-AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO INDEX PROCEDURE, ASPIRIN (100 MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19.0 MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, 126 DAYS POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 45% AND COMPLETE SEAL WITH A LAMINAR, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 0.5 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, THE PATIENT WAS STARTED ON APIXABAN (10 MG) FOR DEVICE THROMBUS. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING.

    Description of Event or Problem · 0

    CHAMPION-AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO INDEX PROCEDURE, ASPIRIN (100 MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19.0 MM. ON (B)(6) 2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, 126 DAYS POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 45% AND COMPLETE SEAL WITH A LAMINAR, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 0.5 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON (B)(6) 2022, THE PATIENT WAS STARTED ON APIXABAN (10 MG) FOR DEVICE THROMBUS. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. IT WAS FURTHER CLARIFIED THAT (B)(6) 2022 WAS 116 DAYS POST PROCEDURE WHEN THE FOUR MONTH FOLLOW UP TEE WAS PERFORMED. IT WAS FURTHER REPORTED THAT ON (B)(6) 2023, THE PATIENT HAD AN UNSCHEDULED VISIT FOR ADDITIONAL PROTOCOL REQUIRED IMAGING TO CONFIRM THE RESOLUTION OF THE PREVIOUS THROMBUS AND TEE ASSESSMENT PERFORMED ON (B)(6) 2023 REVEALED ESTIMATED LVEF OF 35% WITH COMPLETE SEAL AND NO EVIDENCE OF THROMBUS ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE OR LEFT ATRIUM AND NO EVIDENCE OF PERICARDIAL EFFUSION.

    Description of Event or Problem · 0

    CHAMPION-AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. PRIOR TO INDEX PROCEDURE, ASPIRIN (100 MG) WAS ADMINISTERED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX LAA CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 19.0 MM. ON 22JUN2022, THE PATIENT WAS DISCHARGED ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON 14OCT2022, 126 DAYS POST INDEX PROCEDURE, TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT REVEALED LEFT VENTRICULAR EJECTION FRACTION OF 45% AND COMPLETE SEAL WITH A LAMINAR, NON-MOBILE THROMBUS WITH MAXIMUM AREA OF 0.5 CM2 ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX DEVICE. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN (100 MG) AND CLOPIDOGREL (75 MG). ON 17OCT2022, THE PATIENT WAS STARTED ON APIXABAN (10 MG) FOR DEVICE THROMBUS. AT THE TIME OF REPORTING, THE EVENT WAS ONGOING. IT WAS FURTHER CLARIFIED THAT 14OCT2022 WAS 116 DAYS POST PROCEDURE WHEN THE FOUR MONTH FOLLOW UP TEE WAS PERFORMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2796203 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0029276816

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Female Other