BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 6045226 · Received October 20, 2016

    Report

    Report Number
    2916596-2016-02049
    Event Type
    Death
    Date Received
    October 20, 2016
    Date of Event
    September 3, 2016
    Report Date
    September 26, 2016
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IT
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    A CORRELATION BETWEEN THE DEVICE AND THE REPORTED HEMORRHAGIC STROKE COULD NOT BE CONCLUSIVELY DETERMINED. 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.

    Additional Manufacturer Narrative · 1

    (B)(4). APPROXIMATE AGE OF DEVICE ¿ 1 YEAR, 1 MONTH. THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT AND THEREFORE IS NOT EXPECTED TO BE RETURNED FOR EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETE.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2015. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2016 DUE TO A CEREBRAL HEMORRHAGE. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694579 HEARTMATE II LVAS, EUROPE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106016

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death