BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 6145490 · Received December 5, 2016

    Report

    Report Number
    2916596-2016-02339
    Event Type
    Death
    Date Received
    December 5, 2016
    Date of Event
    October 28, 2015
    Report Date
    November 8, 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

    THE REFERENCED PUMP EXCHANGE ON (B)(6) 2015 WAS REPORTED UNDER MEDWATCH MFR REPORT # 2916596-2015-01558. THE REFERENCED PUMP EXCHANGE ON (B)(6) 2015 WAS REPORTED UNDER MEDWATCH MFR REPORT # 2916596-2015-02098. DEVICE UNIQUE IDENTIFIER (UDI) # (B)(4). APPROXIMATE AGE OF DEVICE ¿ 14 DAYS. A CORRELATION BETWEEN THE DEVICE AND THE REPORTED SEPSIS AND CHRONIC DRIVELINE AND POSSIBLE PUMP POCKET INFECTIONS COULD NOT BE CONCLUSIVELY DETERMINED. SEPSIS AND INFECTION ARE LISTED IN THE INSTRUCTIONS FOR USE AS POTENTIAL ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF 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 ORIGINALLY IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. ON (B)(6) 2015 THE PATIENT UNDERWENT PUMP EXCHANGES FOR CHRONIC, SEVERE DRIVELINE INFECTION, AND POSSIBLE PUMP POCKET INFECTION. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2015 FROM MULTISYSTEM ORGAN FAILURE SECONDARY TO SEPSIS. THERE WERE NO REPORTED ISSUES WITH THE FUNCTION OF THE DEVICES THAT HAD SUPPORTED THE PATIENT. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    795590 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Death