BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 13654083 · Received March 2, 2022

    Report

    Report Number
    2134265-2022-02219
    Event Type
    Injury
    Date Received
    March 2, 2022
    Date of Event
    February 23, 2022
    Report Date
    June 7, 2022
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860518
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: EVENT DESCRIPTION UPDATED.

    Additional Manufacturer Narrative · 0

    B5: EVENT DESCRIPTION UPDATED.

    Description of Event or Problem · 0

    (B)(6) STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED SUCCESSFULLY USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE ON ASPIRIN 81MG AND RIVAROXABAN 20MG. RIVAROXABAN WAS DISCONTINUED THREE MONTHS POST PROCEDURE, (B)(6) 2022, BUT THE PATIENT REMAINED TAKING ASPIRIN 81MG. ON (B)(6) 2021, 121 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A ROUTINE FOLLOW UP OF LAA IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT. A MOBILE, PEDUNCULATED THROMBUS WAS DISCOVERED ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE THROMBUS HAD A MAXIMUM AREA OF 1.3CM2. UPON DISCOVERY OF THE THROMBUS, THE PATIENT WAS PRESCRIBED RIVAROXABAN 20MG AND CONTINUED TAKING ASPIRIN 81MG. NO PATIENT COMPLICATIONS WERE NOTED.

    Description of Event or Problem · 0

    CHAMPION AF STUDY. IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED SUCCESSFULLY USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE ON ASPIRIN 81MG AND RIVAROXABAN 20MG. RIVAROXABAN WAS DISCONTINUED THREE MONTHS POST PROCEDURE, (B)(6) 2022, BUT THE PATIENT REMAINED TAKING ASPIRIN 81MG. ON (B)(6) 2021, 121 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A ROUTINE FOLLOW UP OF LAA IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT. A MOBILE, PEDUNCULATED THROMBUS WAS DISCOVERED ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE THROMBUS HAD A MAXIMUM AREA OF 1.3CM2. UPON DISCOVERY OF THE THROMBUS, THE PATIENT WAS PRESCRIBED RIVAROXABAN 20MG AND CONTINUED TAKING ASPIRIN 81MG. NO PATIENT COMPLICATIONS WERE NOTED. PREVIOUSLY IT WAS REPORTED THAT THE THROMBUS ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE MEASURED 1.3CM2. IT WAS FURTHER REPORTED THE SIZE OF THE THROMBUS MEASURED 0.4CM2.

    Description of Event or Problem · 0

    CHAMPION AF STUDY. IT WAS REPORTED THAT A THROMBUS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED SUCCESSFULLY USING A 31MM WATCHMAN FLX LAA CLOSURE DEVICE WITH DELIVERY SYSTEM (WDS). THE PATIENT WAS DISCHARGED ONE DAY POST INDEX PROCEDURE ON ASPIRIN 81MG AND RIVAROXABAN 20MG. RIVAROXABAN WAS DISCONTINUED THREE MONTHS POST PROCEDURE, (B)(6) 2022, BUT THE PATIENT REMAINED TAKING ASPIRIN 81MG. ON (B)(6) 2021, 121 DAYS POST INDEX PROCEDURE, THE PATIENT UNDERWENT A ROUTINE FOLLOW UP OF LAA IMAGING AND TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) ASSESSMENT. A MOBILE, PEDUNCULATED THROMBUS WAS DISCOVERED ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE. THE THROMBUS HAD A MAXIMUM AREA OF 1.3CM2. UPON DISCOVERY OF THE THROMBUS, THE PATIENT WAS PRESCRIBED RIVAROXABAN 20MG AND CONTINUED TAKING ASPIRIN 81MG. NO PATIENT COMPLICATIONS WERE NOTED. PREVIOUSLY IT WAS REPORTED THAT THE THROMBUS ON THE ATRIAL FACING SURFACE OF THE CLOSURE DEVICE MEASURED 1.3CM2. IT WAS FURTHER REPORTED THE SIZE OF THE THROMBUS MEASURED 0.4CM2. IT WAS FURTHER REPORTED THAT ON (B)(6) 2022 THE PATIENT UNDERWENT A TEE ASSESSMENT WHICH REVEALED NO PRESENCE OF THE THROMBUS AND THE PHYSICIAN CONSIDERED THE EVENT RESOLVED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1953940 WATCHMAN FLX LEFT ATRIAL APPENDAGE CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION 10390 0027431679 08714729860518

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Male Other