BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2431791 · Received January 25, 2012

    Report

    Report Number
    2916596-2012-00049
    Event Type
    Death
    Date Received
    January 25, 2012
    Date of Event
    December 30, 2011
    Report Date
    December 30, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXPLANTED DEVICE WAS RETURNED TO THE MFR FOR EVAL AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETE.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT AFTER APPROXIMATELY TWO MONTHS OF SUPPORT, THE PT WAS HAVING GASTROINTESTINAL (GI) BLEEDING ISSUES AND MULTI-SYSTEM ORGAN FAILURE (MSOF). PER ADD'L INFO PROVIDED, THE PT WAS HAVING POWER SPIKES AND HEMOLYSIS. A DECISION WAS MADE TO WITHDRAW SUPPORT AND THE PT EXPIRED. THE HOSPITAL ALSO REPORTED THAT, UPON EXPLANT OF THE DEVICE (POST MORTEM), A CLOT WAS NOTED AND REMOVED FROM THE PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 105834

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Death