BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX? PRO

    MDR report key: 22196348 · Received June 12, 2025

    Report

    Report Number
    2124215-2025-38119
    Event Type
    Injury
    Date Received
    June 12, 2025
    Date of Event
    January 1, 2025
    Report Date
    September 3, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004606
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SD, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    A.2. DATE OF BIRTH: UPDATED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED. THE PATIENT HAD A ROUTINE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IN (B)(6) 2025 AND DEVICE RELATED THROMBUS WAS NOTED ON THE CLOSURE DEVICE. THE PATIENT CONTINUED ON ORAL ANTICOAGULATION (OAC) MEDICATION. A FOLLOW UP WAS COMPLETED IN (B)(6) 2025 AND THE THROMBUS WAS STILL PRESENT BUT HAD DECREASED IN SIZE. THE PATIENT CONTINUED ON OAC MEDICATION. THE PATIENT RETURNED FOR A THIRD FOLLOW UP (B)(6) 2025 AND THE THROMBUS WAS STILL PRESENT, BUT WAS NOTED TO HAVE CONTINUED TO DECREASE IN SIZE. THE PATIENT WILL CONTINUE ON OAC AND WILL BE REEVALUATED IN ANOTHER 45 DAYS.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED, AND A 27MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED ON (B)(6) 2024. THE PATIENT WAS DISCHARGED. THE PATIENT HAD A ROUTINE 45-DAY FOLLOW-UP TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IN (B)(6) 2025 AND DEVICE RELATED THROMBUS WAS NOTED ON THE CLOSURE DEVICE. THE PATIENT CONTINUED ON ORAL ANTICOAGULATION (OAC) MEDICATION. A FOLLOW UP WAS COMPLETED IN (B)(6) 2025 AND THE THROMBUS WAS STILL PRESENT BUT HAD DECREASED IN SIZE. THE PATIENT CONTINUED ON OAC MEDICATION. THE PATIENT RETURNED FOR A THIRD FOLLOW UP (B)(6) 2025 AND THE THROMBUS WAS STILL PRESENT, BUT WAS NOTED TO HAVE CONTINUED TO DECREASE IN SIZE. THE PATIENT WILL CONTINUE ON OAC AND WILL BE REEVALUATED IN ANOTHER 45 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1362105 WATCHMAN FLX? PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60270 0034588999 00191506004606

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Female Other