BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6072559 · Received November 2, 2016

    Report

    Report Number
    2916596-2016-02136
    Event Type
    Death
    Date Received
    November 2, 2016
    Date of Event
    October 2, 2016
    Report Date
    October 13, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 39 DAYS. THE DEVICE WAS RETURNED FOR INVESTIGATION. THE EVALUATION IS NOT YET COMPLETE. THE EVENT OCCURRED AT (B)(6) HOSPITAL, (B)(6). NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A DIRECT CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMORRHAGIC STROKE COULD NOT BE CONCLUSIVELY DETERMINED. EXAMINATION OF THE PUMP BLOOD-CONTACTING SURFACES REVEALED NO ADHERED DEPOSITIONS OR THROMBUS FORMATIONS. VISUAL INSPECTION OF THE PUMP BEARINGS AND BEARING CUPS FOUND NO ANOMALIES RELATED TO WEAR OR DAMAGE. EXAMINATION OF THE PERCUTANEOUS LEAD FOUND IT TO BE UNREMARKABLE. ELECTRICAL CONTINUITY TESTING OF THE WIRES FOUND NO DISCONTINUITIES OR SHORTS. THE PUMP WAS REASSEMBLED AND OPERATED ON A MOCK CIRCULATORY LOOP AND FUNCTIONED AS INTENDED. STROKE AND BLEEDING ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS REVEALED NO DEVIATIONS FROM MANUFACTURING OR QUALITY ASSURANCE SPECIFICATIONS. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. IT WAS REPORTED THAT THE PATIENT HAD A HEMORRHAGIC STROKE AND EXPIRED ON (B)(6) 2016. ADDITIONAL INFORMATION WAS REQUESTED, BUT HAS NOT BEEN PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    723935 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death