BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3121606 · Received May 16, 2013

    Report

    Report Number
    2916596-2013-00598
    Event Type
    Death
    Date Received
    May 16, 2013
    Date of Event
    March 2, 2013
    Report Date
    April 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PUMP WILL NOT BE RETURNED TO THE MFR FOR EVAL AS THE PUMP WAS NOT EXPLANTED FROM THE PT. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. APPROX 13 MONTHS POST IMPLANT, THE VAD COORDINATOR REPORTED THAT THE PT WAS EXPERIENCING HEMOLYSIS. THE PT WAS GIVEN TISSUE PLASMINOGEN ACTIVATOR (TPA) THROUGH THE LVAD FOR POSSIBLE VAD THROMBUS BUT THE PT DID NOT RESPOND WELL. IT WAS REPORTED THAT HE BECAME FEBRILE, SEPTIC, AND HAD ELEVATES WHITE BLOOD CELLS. A DECISION WAS MADE TO WITHDRAW CARE AND THE PT EXPIRED DUE TO MULTI ORGAN FAILURE. THE PUMP WILL NOT BE RETURNED FOR EVAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218016 HEARTMATE II LVAS DSQ: LET VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110286

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Death