BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3931306 · Received June 24, 2014

    Report

    Report Number
    2916596-2014-00999
    Event Type
    Death
    Date Received
    June 24, 2014
    Date of Event
    August 21, 2013
    Report Date
    May 27, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    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

    DEVICE EVALUATION: A CORRELATION BETWEEN THE DEVICE AND THE REPORTED PATIENT DEATH COULD NOT BE CONCLUSIVELY DETERMINED. THE VAD COORDINATOR REPORTED THAT "TO THE BEST OF OUR KNOWLEDGE, THE PUMP WAS WORKING." PER THE AUTOPSY REPORT, "THIS PATIENT WITH DILATED CARDIOMYOPATHY STATUS POST LVAD EXPERIENCED VENTRICULAR DYSRHYTHMIA AND CARDIAC ARREST IN THE SETTING OF LVAD FAILURE AND RECENT COCAINE USE THAT LEAD TO ANOXIC BRAIN INJURY AND DEATH." A REVIEW OF THE DEVICE HISTORY RECORD REVEALED THAT THE DEVICE MET APPLICABLE SPECIFICATIONS. NO FURTHER INFORMATION WAS PROVIDED. THE MANUFACTURER IS CLOSING THE FILE ON THIS EVENT.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE. INFO REGARDING THE FOLLOWING EVENT IS SUMMARIZED FROM INFO RECEIVED FROM THE VAD COORDINATOR AND AN AUTOPSY REPORT. ON (B)(6) 2013, THE PT WAS FOUND PULSELESS AND UNRESPONSIVE AT HOME WITH HIS LVAD DISCONNECTED. AN EKG PERFORMED BY EMS REVEALED VENTRICULAR TACHYCARDIA. THE LVAD CONTROLLER SHOWED LOW VOLTAGE ALARMS "CONSISTENT WITH POSSIBLE BATTERY FAILURE." THE PT WAS DEFIBRILLATED THREE TIMES, THE LVAD WAS RECONNECTED AND A PULSE WAS RESTORED; HOWEVER, THE PT REMAINED UNRESPONSIVE. UPON ARRIVAL AT A LOCAL EMERGENCY DEPARTMENT THE PT WAS HYPOTENSIVE; IV MEDICATIONS WERE INITIATED AND HE WAS INTUBATED AND VENTILATED. THE PT WAS TRANSPORTED TO THE IMPLANTING CENTER WHERE HE WAS HEMODYNAMICALLY STABLE WITH SPONTANEOUS EYE OPENING, BUT LACKED OTHER BRAINSTEM REFLEXES. URINE SCREEN WAS POSITIVE FOR COCAINE METABOLITES, BENZODIAZEPINES AND OPIATES. A HEAD CT SCAN SHOWED NO INFARCTION, INTRACEREBRAL HEMORRHAGE OR ANOXIC BRAIN INJURY. AN ELECTROENCEPHALOGRAM (EEG) ON (B)(6) 2013 SHOWED MYOCLONIC STATUS EPILEPTICUS AND SUGGESTED POOR PROGNOSIS FOR NEUROLOGICAL RECOVERY. ECHOCARDIOGRAPHY SHOWED LEFT VENTRICULAR SYSTOLIC DYSFUNCTION, SEVERE LEFT VENTRICULAR HYPOKINESIS, AND PARADOXICAL SEPTAL MOTION. FOR THE NEXT TWO DAYS THE PT REMAINED HEMODYNAMICALLY STABLE WITH ARTIFICIAL PACING AND ADEQUATE LVAD FLOW, BUT HIS NEUROLOGICAL STATUS DID NOT IMPROVE. EEGS SHOWED NO CORTICAL ACTIVITY. LIFE SUPPORT WAS ELECTIVELY WITHDRAWN PER FAMILY WISHES AND THE PT EXPIRED ON (B)(6) 2013. THE AUTOPSY CONFIRMED CARDIOMEGALY WITH FOUR CHAMBER DILATATION AND AN LVAD WITH NORMAL POSITIONING OF THE INFLOW AND OUTFLOW CANNULAE. THERE WAS EVIDENCE OF MILD RIGHT VENTRICULAR HYPERTROPHY, LIKELY REFLECTING A COMBINATION OF PRE-LVAD RIGHT HEART STRAIN FROM CHRONIC LEFT HEART FAILURE AND POST LVAD-ASSOCIATED RIGHT VENTRICULAR REMODELING. POST-MORTEM FINDINGS INCLUDED ACUTE MULTIFOCAL SUBARACHNOID HEMORRHAGE, LIKELY A RESULT OF A GENERAL BLEEDING DIATHESIS IN THE SETTING OF HEPARIN ANTICOAGULATION. AUTOPSY SUMMARY: THE PT EXPERIENCED VENTRICULAR DYSRHYTHMIA AND CARDIAC ARREST IN THE SETTING OF LVAD FAILURE AND RECENT COCAINE USE THAT LED TO ANOXIC BRAIN INJURY AND DEATH. THE VAD COORDINATOR REPORTED, "TO THE BEST OF OUR KNOWLEDGE THE PUMP WAS WORKING. THE PT HAD A DRUG ADDICTION TO COCAINE AND OPIATES AND WAS NOT ALWAYS COMPLIANT WITH HIS COUMADIN." NO ADDITIONAL INFO WAS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    367415 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 110861

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Death