BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 6081001 · Received November 7, 2016

    Report

    Report Number
    2916596-2016-02164
    Event Type
    Death
    Date Received
    November 7, 2016
    Date of Event
    November 10, 2015
    Report Date
    October 13, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE ¿ 1 YEAR, 1 MONTH. THE EVENT OCCURED IN (B)(6). THE PUMP WAS NOT EXPLANTED FROM THE PATIENT AND THEREFORE WAS NOT RETURNED FOR EVALUATION. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED EVENT COULD NOT BE DETERMINED. INFECTION AND SEPSIS ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF THE DEVICE HISTORY RECORDS, INCLUDING STERILIZATION AND PACKAGING DOCUMENTATION, FOUND NO DEVIATIONS FROM MANUFACTURING SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. 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 (LVAD). IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 DUE TO SEPSIS AND MULTISYSTEM ORGAN FAILURE. REPORTEDLY, THE SOURCE OF THE SEPSIS WAS THE DRIVELINE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    735091 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death