BEUDAMED
    FDA Adverse Event Injury Summary report: N

    WATCHMAN FLX PRO

    MDR report key: 20920681 · Received December 12, 2024

    Report

    Report Number
    2124215-2024-77932
    Event Type
    Injury
    Date Received
    December 12, 2024
    Date of Event
    November 27, 2024
    Report Date
    December 17, 2024
    Manufacturer
    BOSTON SCIENTIFIC CORPORATION
    Product Code
    NGV
    PMA / PMN Number
    P130013
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    B5: INFORMATION ADDED. H6 PATIENT CODE ADDED: HIGH BLOOD PRESSURE / HYPERTENSION.

    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 APIXABAN. 153 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF DIZZINESS AND DIPLOPIA. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSTIC IMAGING AND LAB TESTS WERE PERFORMED. BASED ON ASSESSMENT, THE PATIENT WAS DIAGNOSED WITH LEFT THALAMIC LACUNAR ISCHEMIC STROKE, AND MECHANISM OF STROKE WAS SMALL VESSEL DISEASE, THE PATIENT WAS TREATED WITH TENECTEPLASE (TNK). NIHSS PERFORMED TWO DAYS AFTER PRESENTING TO THE HOSPITAL WAS 1, AND THE PATIENT WAS DISCHARGED HOME.

    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 APIXABAN. 153 DAYS POST INDEX PROCEDURE, THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH COMPLAINTS OF DIZZINESS AND DIPLOPIA. AT THE TIME OF THE EVENT, THE PATIENT WAS ON ASPIRIN. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND DIAGNOSTIC IMAGING AND LAB TESTS WERE PERFORMED. BASED ON ASSESSMENT, THE PATIENT WAS DIAGNOSED WITH LEFT THALAMIC LACUNAR ISCHEMIC STROKE, AND MECHANISM OF STROKE WAS SMALL VESSEL DISEASE, THE PATIENT WAS TREATED WITH TENECTEPLASE (TNK). (B)(6) PERFORMED TWO DAYS AFTER PRESENTING TO THE HOSPITAL WAS 1, AND THE PATIENT WAS DISCHARGED HOME. IT WAS FURTHER REPORTED THE PATIENT PRESENTED ALSO WITH A BLOOD PRESSURE OF 204/80, HEART RATE OF 58RPM AND NORMAL SINUS RHYTHM. A COMPUTED TOMOGRAPHY ANGIOGRAM OF THE HEAD AND NECK REVEALED SHORT-SEGMENT STENOSIS OF THE LEFT VERTEBRAL ARTERY AND NO LARGE VESSEL OCCLUSION, ASYMMETRIC HYPOATTENUATION IN THE LEFT BRACHIUM PONTIS AND LEFT CEREBELLAR HEMISPHERE. THE PATIENTS' BLOOD PRESSURE TWO DAYS AFTER PRESENTING TO THE HOSPITAL WAS NOTED TO BE 129/60 WITHOUT INTERVENTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2412353 WATCHMAN FLX PRO SYSTEM, APPENDAGE CLOSURE, LEFT ATRIAL NGV BOSTON SCIENTIFIC CORPORATION M635WU60310 0033292459

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention| H