BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAD

    MDR report key: 3113559 · Received May 10, 2013

    Report

    Report Number
    2916596-2013-00578
    Event Type
    Death
    Date Received
    May 10, 2013
    Date of Event
    April 10, 2013
    Report Date
    April 12, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR WAS ADVISED THAT THE EXPLANTED LVAD PUMP WILL NOT BE RETURNING FOR EVAL AS IT HAS BEEN DISPOSED OF. 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). IT WAS REPORTED BY THE VAD COORDINATOR THAT THE PATIENT HAD PACER WIRES REMOVED WITH INR AT 1.5, FORTY MINUTES LATER, THE PATIENT'S BLOOD PRESSURE DROPPED AND CONTINUED OVER 2.5 HOURS. DURING THIS TIME, THE PATIENT WAS RECEIVING HEMODIALYSIS AT BEDSIDE. THE STAFF BELIEVED THE OCCURRENCE OF THE BLOOD PRESSURE WAS DUE TO FLUID REMOVAL FROM DIALYSIS. THE PATIENT CONTINUED TO DECLINE AND THE PATIENT'S CHEST WAS CRACKED AT BEDSIDE BY THE PHYSICIAN. THE PATIENT WAS THEN STABILIZED AND TAKEN TO THE OPERATING ROOM WHERE SEVERAL CLOTS WERE REMOVED AND PATIENT WAS GIVEN RVAD SUPPORT AND MAXED ON DRIPS. THE PATIENT'S FAMILY MADE THE DECISION TO WITHDRAW CARE. NO AUTOPSY WAS PERFORMED AND THE PUMP WAS DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    206103 HEARTMATE II LVAD DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 124151

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Death