BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3961768 · Received June 17, 2014

    Report

    Report Number
    2916596-2014-01147
    Event Type
    Death
    Date Received
    June 17, 2014
    Date of Event
    March 1, 2013
    Report Date
    June 22, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER WAS ADVISED THAT THE DEVICE WILL NOT BE RETURNING FOR EVALUATION AS IT WAS NOT EXPLANTED. 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). INFORMATION WAS PROVIDED TO THE MANUFACTURER THROUGH THEIR DEVICE TRACKING SYSTEM INDICATING THAT THE PATIENT EXPIRED. THE CAUSE OF EXPIRATION NOTED AS "PUMP THROMBUS". INFORMATION PROVIDED BY THE PERFUSIONIST INDICATED THAT THE CENTER NEVER CONFIRMED PUMP THROMBUS ALTHOUGH THERE WAS A LITTLE SUSPICION ABOUT IT DUE TO SOME MINOR POWER ELEVATIONS AND ELEVATED LACTATE DEHYDROGENASE. POWER ELEVATIONS WERE AS HIGH AS 11.1 WATTS AND LACTATE DEHYDROGENASE OF 2375 WAS NOTED. MANY OTHER MEDICAL COMPLICATIONS OCCURRED AT SAME TIME: THREE DAYS PREVIOUS , THE PATIENT HAD A CVA AND THE PROGNOSIS WAS POOR. TREATMENT WAS WITHDRAWN AND THE CAUSE OF DEATH WAS EMBOLIC STROKE. THE PUMP WAS NOT EXPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    355979 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 122807

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death