BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 2251009 · Received September 13, 2011

    Report

    Report Number
    2916596-2011-00389
    Event Type
    Death
    Date Received
    September 13, 2011
    Date of Event
    August 16, 2011
    Report Date
    August 16, 2011
    Manufacturer
    THORATEC CORP
    Product Code
    DSQ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE ATTACHED USER FACILITY REPORT WAS RECEIVED FROM THE (B)(4) REGISTRY. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE PERFUSIONIST REPORTED THAT APPROXIMATELY TWO MONTHS POST IMPLANT OF THE LVAD, THE HOSPITAL SUSPECTED THIS "TERMINAL" PT HAD A POSSIBLE CLOT IN THE PUMP. IT WAS REPORTED THAT THE PUMP TELEMETRY DISPLAYED ON THE SYSTEM MONITOR INDICATED "LOW FLOW", PUMP STOPPAGE WITH THE PUMP SPEED AT 0 RPM, VARIABLE PI LEVELS AND PUMP POWER SPIKES OF 23-30 WATTS. THE PUMP SOUND WAS REPORTEDLY FORM HUMMING TO DRAGGING. THE PT'S HEPARIN DOSAGE WAS LOWERED DUE TO PREVENT GI BLEEDING. THE PT WAS PULSATILE WITH A SYSTOLIC BLOOD PRESSURE OF 60 AND WAS NOT RESPONSIVE. THE PT'S CONDITION HAD PROGRESSIVELY DECLINED AND THE HOSPITAL DID NOT BELIEVE THE PT WAS A CANDIDATE FOR A PUMP EXCHANGE. ADDITIONAL INFORMATION PROVIDED INDICATED THAT THE PT ULTIMATELY EXPIRED (NOT DEVICE RELATED) AND THE PT'S FAMILY REFUSED AUTOPSY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP 104911 104772

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Death