BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3121634 · Received May 10, 2013

    Report

    Report Number
    2916596-2013-00569
    Event Type
    Death
    Date Received
    May 10, 2013
    Date of Event
    March 8, 2013
    Report Date
    April 12, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE USER FACILITY REPORT ((B)(4)) WAS RECEIVED FROM THE (B)(4) REGISTRY. THE PUMP WILL NOT BE RETURNED TO THE MFR FOR EVAL, AS THE PUMP WAS NOT EXPLANTED. NO AUTOPSY WAS PERFORMED AND A DEATH CERTIFICATE WAS NOT PROVIDED TO THE HOSPITAL AS THE PATIENT EXPIRED AT A HOSPICE HOUSE. NO FURTHER INFO 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 PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE MFR RECEIVED THE USER FACILITY REPORT ((B)(4)) FROM THE (B)(4) REGISTRY. THE REPORT INDICATED THAT THE PATIENT WAS ADMITTED INTO THE HOSPITAL WITH FATIGUE AND DARK URINE. THE PATIENT WAS FOUND TO HAVE LOW HEMOGLOBIN, ELEVATED PLASMA FREE HEMOGLOBIN (PF HGB), WORSENING RIGHT HEART FUNCTION BY RIGHT HEART CATHETERIZATION (RHC), AND ECHO. HE ALSO HAD POOR RESPONSE TO MEDICAL MANAGEMENT. THE PATIENT WAS NOT A SURGICAL CANDIDATE AND WAS DISCHARGED TO A HOSPICE HOUSE. ADD'L INFO WAS RECEIVED FROM THE HOSPITAL'S VAD COORDINATOR THAT THE PATIENT HAD EXPIRED AT THE HOSPICE HOUSE, DUE TO RIGHT HEART FAILURE AND MULTI-SYSTEM ORGAN FAILURE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    207174 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 85199

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death