BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX?

    MDR report key: 24533241 · Received March 6, 2026

    Report

    Report Number
    2124215-2026-12596
    Event Type
    Injury
    Date Received
    March 6, 2026
    Date of Event
    June 25, 2022
    Report Date
    April 7, 2026
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    08714729860495
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    REPORTED VIA CLINICAL STUDY. IT WAS REPORTED THAT A TRANSIENT ISCHEMIC ATTACK (TIA) OCCURRED. ON (B)(6) 2022, THE PATIENT UNDERWENT A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WITH SUCCESSFUL PLACEMENT OF A 24 MM WATCHMAN FLX CLOSURE DEVICE WITH A DEPLOYED DEVICE DIAMETER OF 18.1 MM. THE PATIENT WAS DISCHARGED THE SAME DAY ON APIXABAN (10 MG/DAY) AND ASPIRIN (81 MG/DAY). ON (B)(6) 2022, 94 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY ROOM (ER) WITH SUDDEN ONSET OF CONFUSION AND GOT DIAGNOSED WITH TRANSIENT GLOBAL AMNESIA (TGA). THE PATIENT WAS ON ASPIRIN (81 MG /DAY) AT THE TIME OF THE EVENT. THE PATIENT WAS ADMITTED TO THE HOSPITAL FOR FURTHER EVALUATION. THE NEXT DAY, MAGNETIC RESONANCE IMAGING (MRI) OF THE BRAIN WAS PERFORMED WHICH RESULTED WITHOUT ANY EVIDENCE OF ISCHEMIA. THE EVENT WAS CLASSIFIED AS TIA. ON (B)(6) 2022, THE EVENT WAS CONSIDERED TO BE RESOLVED. THE PATIENT REMAINED STABLE AND WAS DISCHARGED HOME ON ASPIRIN (81 MG/DAY).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    435030 WATCHMAN FLX? SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU50240 0028911981 08714729860495

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Male Hospitalization| O