BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM

    MDR report key: 8883069 · Received August 12, 2019

    Report

    Report Number
    2916596-2019-03743
    Event Type
    Death
    Date Received
    August 12, 2019
    Date of Event
    July 25, 2019
    Report Date
    October 21, 2019
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    UDI-DI
    00813024011170
    PMA / PMN Number
    P060040
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    A DIRECT CORRELATION BETWEEN THE REPORTED RIGHT HEART FAILURE AND HEARTMATE II LVAS,PUMP COULD NOT BE CONCLUSIVELY ESTABLISHED THROUGH THIS EVALUATION. THE ACCOUNT COMMUNICATED THAT THE PATIENT HAD EXPIRED ON (B)(6) 2019 DUE TO RIGHT HEART FAILURE. NO KNOWN ALARMS WERE REPORTED FOR THIS EVENT. THE PATIENT WAS DIAGNOSED WITH RIGHT HEART FAILURE AFTER LVAD IMPLANTATION. THE DEVICE REPORTEDLY OPERATED AS EXPECTED AND WILL NOT BE RETURNED FOR EVALUATION. THE HMII LVAS IFU LISTS RIGHT HEART FAILURE AS AN ADVERSE EVENT THAT MAY BE ASSOCIATED WITH THE USE OF THE HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THE EVENT.

    Additional Manufacturer Narrative · 1

    APPROXIMATE AGE OF DEVICE 7 YEARS, 2 MONTHS. NO FURTHER INFORMATION WAS PROVIDED. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER¿S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD) ON (B)(6) 2012. IT WAS REPORTED THAT THE PATIENT EXPIRED ON (B)(6) 2019 DUE TO RIGHT HEART FAILURE. THE DEVICE TRACKING NUMBER HAS BEEN ADDED TO CS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    679492 HEARTMATE II LEFT VENTRICULAR ASSIST SYSTEM LEFT VENTRICULAR ASSIST SYSTEM DSQ THORATEC CORPORATION 104911 00813024011170

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Death| H