BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LVAS

    MDR report key: 3192675 · Received June 25, 2013

    Report

    Report Number
    2916596-2013-00800
    Event Type
    Death
    Date Received
    June 25, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 28, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ACCORDING TO THE INFO PROVIDED TO THE MFR, THE EXPLANTED LVAD WAS DISPOSED OF BY THE HOSPITAL. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Additional Manufacturer Narrative · 1

    THE PUMP WAS NOT EXPLANTED - EXPLANT DATE REMOVED. DUE TO THE DEVICE NOT BEING AVAILABLE FOR EVALUATION, A CORRELATION BETWEEN THE LVAD AND THE REPORTED EVENT COULD NOT CONCLUSIVELY BE DETERMINED. HOWEVER THE DEVICE¿S APPROVED LABELING LISTS DEVICE THROMBOSIS, BLEEDING, NEUROLOGIC DYSFUNCTION, AND DEATH AS ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF THE LEFT VENTRICULAR ASSIST SYSTEM. A REVIEW OF DEVICE HISTORY RECORDS SHOWED NO DEVIATIONS FROM MANUFACTURING OR QA SPECIFICATIONS. NO FURTHER INFORMATION IS AVAILABLE. THE MANUFACTURER IS CLOSING ITS FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE TRANSPLANT COORDINATOR REPORTED THAT THE PT WOKE UP WITH A SEVERE HEADACHE, DIAPHORETIC, VOMITING, AND ALTERED MENTAL STATUS. EMERGENCY MEDICAL SVS (EMS) WAS CONTACTED AND THE PT WAS TAKEN TO THE HOSPITAL. A COMPUTED TOMOGRAPHY (CT) INDICATED A "MASSIVE SUBDURAL HEMORRHAGE", BUT THERE WAS NO HISTORY OF ANY TRAUMA. ON ADMISSION THE PT'S INTERNAL NORMALIZED RATIO (INR) WAS 3.1 COMPARED TO THE PRIOR WEEK OF 2.6. THE PT WAS GIVEN 5 MG OF VITAMIN K IN THE EMERGENCY ROOM (ER). INR DROPPED TO 1.4 AND NEVER GOT ABOVE 2.4. THE PT WAS TAKEN TO THE OPERATING ROOM (OR) AND THE PT DEMONSTRATED SOME POSTURING. ONCE IN THE OPERATING ROOM, A SUBSTANTIAL AMOUNT OF BLOOD AND CLOTS WERE EVACUATED. THERE WAS ALREADY A MIDLINE SHIFT AND SWELLING OF THE BRAIN WITH BRUISING. THE PT WAS TAKEN TO THE NEURO INTENSIVE CARE UNIT (ICU). OVERNIGHT, THE PT HAD A TEMPERATURE OF 105 F WHICH DECREASED TO 99 F THE NEXT MORNING. THE PT'S NEURO STATUS SEEMED TO BE DECLINING AND THERE WERE NO REFLEXES SHOWN BY PT. THE FAMILY DECIDED TO WITHDRAW SUPPORT AND THE PT EXPIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    289280 HEARTMATE II LVAS DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 111371

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Death