BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 6041816 · Received October 19, 2016

    Report

    Report Number
    2916596-2016-02036
    Event Type
    Death
    Date Received
    October 19, 2016
    Date of Event
    July 31, 2016
    Report Date
    September 27, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 4 MONTHS. (B)(4). NO ADDITIONAL INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED SUBARACHNOID HEMORRHAGE, GASTROINTESTINAL BLEEDING, RIGHT HEART FAILURE, AND BACTEREMIA COULD NOT BE CONCLUSIVELY DETERMINED. BLEEDING, STROKE, RIGHT HEART FAILURE, AND INFECTION 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, INCLUDING THE STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING 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 EXPIRED ON (B)(6) 2016 DUE TO A CEREBROVASCULAR ACCIDENT (CVA). IT WAS ALSO REPORTED THAT THE PATIENT EXPERIENCED RIGHT HEART FAILURE, GI BLEEDING AND WAS ON HEMODIALYSIS. THE PATIENT HAD A SUBTHERAPEUTIC INR DUE TO GI BLEEDING AND WAS OFF ON ANTICOAGULATION. THE PATIENT HAD ALSO DEVELOPED BACTEREMIA. POWER FLUCTUATIONS WERE NOTED. A CT SCAN EVENTUALLY INDICATED A SUBARACHNOID HEMORRHAGE THAT WAS INCREASING IN SIZE. NO INTERVENTION WAS PERFORMED AND THE PATIENT EXPIRED. NO FURTHER INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    690176 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death