BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO

    MDR report key: 20925318 · Received December 13, 2024

    Report

    Report Number
    2124215-2024-77815
    Event Type
    Injury
    Date Received
    December 13, 2024
    Date of Event
    October 4, 2024
    Report Date
    January 29, 2025
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    UDI-DI
    00191506004613
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: INFORMATION ADDED. H6 PATIENT CODES ADDED: FACIAL PARALYSIS AND PAIN.

    Description of Event or Problem · 0

    HEAL-LAA STUDY: IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. COMPLETE LAA SEAL WAS NOTED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. 91 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LEFT SIDED WEAKNESS AND NUMBNESS. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND DIAGNOSTIC IMAGING AND LAB TESTS WERE PERFORMED. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN ISCHEMIC STROKE. THE PATIENT WAS TREATED WITH ANTIPLATELET/ANTICOAGULANT AND NON-ANTIPLATELET/NON-ANTICOAGULANT MEDICATION. FIVE (5) DAYS AFTER PRESENTING TO THE HOSPITAL, THE PATIENT WAS DISCHARGE TO A REHABILITATION/SKILLED NURSING FACILITY. IT WAS FURTHER REPORTED THE LEFT SIDED WEAKNESS CONSISTED OF LEFT LEG AND ALSO LEFT-HAND WEAKNESS, PAIN, NUMBNESS, AND MINOR FACIAL PARALYSIS. THE LEFT LEG WEAKNESS WAS IMPROVED BUT LEFT-HAND WEAKNESS REMAINED UNCHANGED. OVERALL SYMPTOMS IMPROVED, AND THE PATIENT WAS IN STABLE CONDITION UPON DISCHARGE TO THE SKILLED NURSING FACILITY. A MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE BRAIN REVEALED ACUTE LACUNAR INFARCT INVOLVING THE RIGHT CORONA RADIATA EXTENDING INTO THE RIGHT LENTIFORM NUCLEUS, MULTIFOCAL NONACUTE INFARCTS AND NO EVIDENCE OF HEMORRHAGE.

    Description of Event or Problem · 0

    HEAL-LAA STUDY. IT WAS REPORTED A STROKE OCCURRED. A LEFT ATRIAL APPENDAGE (LAA) CLOSURE PROCEDURE WAS PERFORMED AND A 31MM WATCHMAN FLX PRO CLOSURE DEVICE WAS IMPLANTED. COMPLETE LAA SEAL WAS NOTED. THE PATIENT WAS DISCHARGED ON ASPIRIN AND CLOPIDOGREL. 91 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF LEFT SIDED WEAKNESS AND NUMBNESS. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN AND CLOPIDOGREL. THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) AND DIAGNOSTIC IMAGING AND LAB TESTS WERE PERFORMED. A COMPUTED TOMOGRAPHY (CT) SCAN REVEALED AN ISCHEMIC STROKE. THE PATIENT WAS TREATED WITH ANTIPLATELET/ANTICOAGULANT AND NON-ANTIPLATELET/NON-ANTICOAGULANT MEDICATION. FIVE (5) DAYS AFTER PRESENTING TO THE HOSPITAL, THE PATIENT WAS DISCHARGE TO A REHABILITATION/SKILLED NURSING FACILITY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1936071 WATCHMAN FLX PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60310 0033403231 00191506004613

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Hospitalization| R