BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO

    MDR report key: 21537089 · Received March 6, 2025

    Report

    Report Number
    2124215-2025-13706
    Event Type
    Injury
    Date Received
    March 6, 2025
    Date of Event
    February 25, 2025
    Report Date
    March 6, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004590
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    IT WAS REPORTED THAT THROMBOSIS OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 24MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. THE PATIENT WAS PLACED ON AN ASPIRIN AND PLAVIX MEDICATION REGIMEN WHICH THE PATIENT HAD BEEN THERAPEUTIC CONSISTENTLY ON. AT THE 45-DAY ROUTINE FOLLOW UP, TRANSESOPHAGEAL ECHOCARDIOGRAPHY (TEE) IMAGING REVEALED A NON-MOBILE DEVICE RELATED THROMBUS (DRT) ON THE FACE OF THE CLOSURE DEVICE. THE PHYSICIANS PLACED THE PATIENT ON THREE (3) MONTHS OF ORAL ANTICOAGULANT (OAC) MEDICATION IN RESPONSE TO THE EVENT. NO FURTHER INTERVENTIONS OR PATIENT COMPLICATIONS WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    798699 WATCHMAN FLX PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60240 0034648311 00191506004590

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Male Other