BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE 3 LVAS IMPLANT KIT

    MDR report key: 10087814 · Received May 26, 2020

    Report

    Report Number
    2916596-2020-02657
    Event Type
    Death
    Date Received
    May 26, 2020
    Date of Event
    May 9, 2020
    Report Date
    June 22, 2020
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024013297
    PMA / PMN Number
    P160054
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NE, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    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 · 1

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

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT EXPIRED DUE TO STROKE. PER THE VAD COORDINATOR, THE DEVICE OPERATED AS INTENDED. THE DEVICE WILL NOT BE RETURNED FOR EVALUATION. CT SCAN SHOWED THAT THE STROKE TYPE WAS M1 OCCLUSION WITH HEMISPHERIC STROKE AND CEREBELLAR INFARCTS. PATIENT DEVELOPED IT AFTER IMPLANT ON (B)(6) 2020. RADIOLOGIST REPORT REVEALED DIFFUSE LEFT MIDDLE CEREBRAL ARTERY TERRITORY EDEMA IN THE LEFT CEREBRAL HEMISPHERE WAS MILDLY INCREASED. LEFT CEREBELLAR HEMISPHERE ISCHEMIC CHANGE AND EDEMA WAS UNCHANGED. THE RIGHT CEREBELLAR HEMISPHERE LOW-ATTENUATION NOW APPEARED MORE CONVINCING FOR ISCHEMIC CHANGE AND EDEMA, THOUGH WAS OVERALL UNCHANGED. THERE WAS MILDLY INCREASED MILD RIGHTWARD SHIFT OF THE SEPTUM PELLUCIDUM MEASURING 0.4 CM. MILDLY INCREASED EFFACEMENT OF THE LEFT LATERAL VENTRICLE. UNCHANGED MILD LEFT-SIDED UNCAL SHIFT. UNCHANGED MILD EFFACEMENT OF THE LEFT ASPECT OF THE FOURTH VENTRICLE. NO EVIDENCE OF HEMORRHAGIC TRANSFORMATION. RELATIVELY HIGH DENSITY SERPIGINOUS FOCUS IN THE LEFT FRONTAL LOBE WAS UNCHANGED, AGAIN LIKELY PSEUDOSUBARACHNOID HEMORRHAGE. NO EXTRACEREBRAL FLUID COLLECTIONS. RIGHT-SIDED CEREBRAL HEMISPHERIC WHITE MATTER AND BASAL GANGLIA LOW DENSITIES WERE UNCHANGED. MINIMAL SCATTERED PARANASAL SINUS DISEASE. PARTIALLY IMAGED NASOGASTRIC AND INTUBATION TUBES. THE MASTOIDS AND MIDDLE EAR CAVITIES WERE CLEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    549675 HEARTMATE 3 LVAS IMPLANT KIT VENTRICULAR (ASSISST) BYPASS DSQ THORATEC CORPORATION 106524US 7433493 00813024013297

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Death| L