BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM

    MDR report key: 20439597 · Received October 14, 2024

    Report

    Report Number
    2124215-2024-63639
    Event Type
    Injury
    Date Received
    October 14, 2024
    Date of Event
    September 10, 2024
    Report Date
    October 24, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004620
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    HI, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    H6: IMPACT CODE UPDATED FROM F26: NO HEALTH CONSEQUENCES OR IMPACT TO F2303: MEDICATION REQUIRED.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE HEAL-LAA STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26 MM. ON (B)(6) 2024, 43 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL SCHEDULED 45 DAY FOLLOW UP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ASSESSMENT REVEALED DEVICE POSITION AT OSTIUM WHICH WAS WITHIN 2MM OF THE DESIRED OSTIAL PLANE OF MAXIMUM DIAMETER AND A RESIDUAL JET SIZE NOTED AROUND THE DEVICE WAS AT 4MM. TEE ANGLE WAS 90 DEGREES. NO INTERVENTION WAS PERFORMED OR REQUIRED TO CLOSE THE LEAK. DURING TEE ASSESSMENT, A THROMBUS WAS ALSO OBSERVED ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX PRO CLOSURE DEVICE. THE THROMBUS WAS LAMINAR AND NON-MOBILE. THE MAXIMUM AREA OF DEVICE THROMBUS WAS 0.6 CM. NO ADDITIONAL THROMBUS WAS NOTED IN THE LEFT ATRIUM. THE PATIENT WAS ON A MEDICATION OF ASPIRIN AND APIXABAN AT THE TIME OF THE EVENT.

    Description of Event or Problem · 0

    THE PATIENT WAS ENROLLED IN THE (B)(6) STUDY ON (B)(6) 2024 WITH PATIENT IDENTIFIER (B)(6). IT WAS REPORTED THAT THROMBOSIS OCCURRED. THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 35MM WATCHMAN FLX PRO CLOSURE DEVICE WITH COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 26 MM. ON (B)(6) 2024, 43 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED FOR PROTOCOL SCHEDULED 45 DAY FOLLOW UP. TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) ASSESSMENT REVEALED DEVICE POSITION AT OSTIUM WHICH WAS WITHIN 2MM OF THE DESIRED OSTIAL PLANE OF MAXIMUM DIAMETER AND A RESIDUAL JET SIZE NOTED AROUND THE DEVICE WAS AT 4MM. TEE ANGLE WAS 90 DEGREES. NO INTERVENTION WAS PERFORMED OR REQUIRED TO CLOSE THE LEAK. DURING TEE ASSESSMENT, A THROMBUS WAS ALSO OBSERVED ON THE ATRIAL FACING SURFACE OF THE WATCHMAN FLX PRO CLOSURE DEVICE. THE THROMBUS WAS LAMINAR AND NON-MOBILE. THE MAXIMUM AREA OF DEVICE THROMBUS WAS 0.6 CM. NO ADDITIONAL THROMBUS WAS NOTED IN THE LEFT ATRIUM. THE PATIENT WAS ON A MEDICATION OF ASPIRIN AND APIXABAN AT THE TIME OF THE EVENT. IT WAS FURTHER REPORTED THAT THE PATIENT WAS PRESCRIBED APIXABAN FROM ASPIRIN AND CLOPIDOGREL TO TREAT THE THROMBUS. THE PATIENT HAS BEEN DISCHARGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2270769 WATCHMAN FLX PRO LAA CLOSURE DEVICE WITH DELIVERY SYSTEM SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION WS6035 0033855339 00191506004620

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR Female Other