BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 17244404 · Received July 2, 2023

    Report

    Report Number
    2916596-2023-03914
    Event Type
    Injury
    Date Received
    July 2, 2023
    Date of Event
    June 7, 2023
    Report Date
    July 31, 2023
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MANUFACTURER'S INVESTIGATION CONCLUSION: THE PUMP REMAINS IN USE SUPPORTING THE PATIENT. A CORRELATION BETWEEN THE DEVICE AND THE REPORT OF STROKE COULD NOT BE CONCLUSIVELY DETERMINED. STROKE IS LISTED IN THE INSTRUCTIONS FOR USE AS A POTENTIAL ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF HEARTMATE 3 LEFT VENTRICULAR ASSIST SYSTEM. STROKE HAS BEEN PREVIOUSLY INVESTIGATED AND WILL CONTINUE TO BE MONITORED THROUGH QUALITY DATA REVIEWS, WHICH ARE CONDUCTED ON PRODUCTION AND POST PRODUCT SIGNALS TO EVALUATE IF PRODUCTS ARE CONFORMING TO PRODUCT REQUIREMENTS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Additional Manufacturer Narrative · 0

    NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 0

    THE NEUROLOGICAL DYSFUNCTION RESOLVED WITHOUT SEQUELAE ON (B)(6) 2023.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT PATIENT HAD NEW SUDDEN ONSET LEFT FACIAL DROOP, LEFT SIDED WEAKNESS, AND SLURRED SPEECH. THEY WERE ALSO NOTED TO HAVE ALTERED MENTAL STATUS AT THE TIME OF EMERGENCY MEDICAL SERVICES (EMS) ARRIVAL. MODIFIED RANKIN SCORE (MRS) WAS 0, NATIONAL INSTITUTES OF HEALTH STROKE SCALE (NIHSS) WAS 1 (LFD), BLOOD PRESSURE WAS 106/107. UPON ARRIVAL TO EMERGENCY DEPARTMENT, COMPUTED TOMOGRAPHY HEAD (CTH) WAS NEGATIVE, COMPUTED TOMOGRAPHY ANGIOGRAPHY (CTA) SHOWED OCCLUSION IN THE PROXIMAL DOMINANT SUPERIOR DIVISION OF RIGHT M2-MCA. THE PATIENT REPORTED HISTORY OF LOW INR OF 1.5 ON (B)(6) 2023.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    22605 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSIST) BYPASS DSQ THORATEC CORPORATION 106524US 8472776 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Male Required Intervention