BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX?

    MDR report key: 24885659 · Received April 15, 2026

    Report

    Report Number
    2124215-2026-20320
    Event Type
    Injury
    Date Received
    April 15, 2026
    Date of Event
    June 18, 2025
    Report Date
    May 15, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860501
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    THE PATIENT WAS A PART OF A CLINICAL STUDY. IT WAS REPORTED A CEREBRAL VASCULAR ACCIDENT (CVA) OCCURRED. ON (B)(6) 2022, A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 27MM WATCHMAN FLX CLOSURE DEVICE WAS IMPLANTED WITH A COMPLETE LAA SEAL AND DEPLOYED DEVICE DIAMETER OF 22 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON ASPIRIN AND RIVAROXABAN. ON (B)(6) 2025, THE PATIENT PRESENTED TO AN OUTSIDE HOSPITAL AFTER A MOTOR VEHICLE ACCIDENT (MVA) FOR EXTENSIVE TREATMENT AND WAS DIAGNOSED WITH TRAUMATIC BRAIN INJURY IN RESPONSE TO THE MVA. AS A RESULT OF THE MVA, A MAGNETIC RESONANCE IMAGING (MRI) SCAN WAS PERFORMED WHICH ALSO REVEALED AN ACUTE BILATERAL ISCHEMIC STROKE WITH ONSET DATE OF JUNE 18, 2025, WHICH WAS 1211 DAYS POST RANDOMIZATION TO THE CLINICAL STUDY. A TRANSESOPHAGEAL ECHOCARDIOGRAM (TEE) WAS PERFORMED AND WAS NEGATIVE FOR THROMBUS AND NEUROLOGY WAS CONCERNED FOR MICRO-EMBOLI, SO THE PHYSICIANS PLAN TO START THE PATIENT ON ELIQUIS ONCE STABLE. THE PATIENT WAS TREATED AND EVENTUALLY DISCHARGED TO A SKILLED NURSING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    571756 WATCHMAN FLX? SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU50270 0028751997 08714729860501

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Male Hospitalization| R