BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 5534703 · Received March 30, 2016

    Report

    Report Number
    3007042319-2016-01420
    Event Type
    Death
    Date Received
    March 30, 2016
    Date of Event
    March 7, 2014
    Report Date
    March 20, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT WAS ADMITTED TO THE HOSPITAL WITH A SUBARACHNOID HEMORRHAGE. THE PATIENT'S CONDITION DID NOT IMPROVE AND THE FAMILY DECIDED TO WITHDRAW CARE. BLOOD CULTURES WERE DRAWN BUT WERE NOT AVAILABLE UNTIL AFTER THE PATIENT'S DEATH; THE BLOOD CULTURES WERE POSITIVE FOR STREPTOCOCCUS MITIS. THE HVAD PUMP ((B)(4)) AND A BATTERY ((B)(4)) WERE NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICES MET ALL REQUIREMENTS FOR RELEASE. THE CONTROLLERS, BATTERIES, BATTERY CHARGER, CAC ADAPTER, AND CDC ADAPTER WERE RETURNED TO THE MANUFACTURER FOR EVALUATION. THE RETURNED CONCOMITANT DEVICES (B)(4) PASSED VISUAL INSPECTION AND FUNCTIONAL TESTING. THE RETURNED CDC ADAPTER (B)(4) PASSED EXTERNAL VISUAL INSPECTION BUT FAILED FUNCTIONAL TESTING AS A RESULT OF DAMAGED INTERNAL COMPONENTS. CONTROLLER (B)(4) PASSED VISUAL AND FUNCTIONAL TESTING BUT REVIEW OF LOG FILES REVEALED A DEPLETED REAL TIME CLOCK BATTERY. THESE WERE BOTH INCIDENTAL FINDINGS NOT RELATED TO THE REPORTED EVENT. THE BATTERIES REPORTED IN THIS COMPLAINT ((B)(4)) WERE REMOVED FROM THE MARKET AS PART OF FSCA APR2014.1 AND WERE DESTROYED AS PART OF THE REQUIRED ACTIONS; THEREFORE, THE DEVICES WERE NOT AVAILABLE FOR ANALYSIS. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT CANNOT BE CONCLUSIVELY DETERMINED; HOWEVER, THERE ARE PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. DEATH, INFECTION, AND STROKE ARE KNOWN RISKS ASSOCIATED WITH USE OF VENTRICULAR ASSIST DEVICES NOTED WITHIN THE LABELING. THE VENTRICULAR ASSIST SYSTEM IS INDICATED FOR USE AS A BRIDGE TO CARDIAC TRANSPLANTATION IN PATIENTS WHO ARE AT RISK OF DEATH FROM REFRACTORY END-STAGE LEFT VENTRICULAR HEART FAILURE. THE SYSTEM IS DESIGNED FOR IN-HOSPITAL AND OUT-OF-HOSPITAL SETTINGS, INCLUDING TRANSPORTATION. HEARTWARE IS SUBMITTING THIS REPORT AS A RESULT OF REMEDIATION ACTIVITIES RELATED TO FDA WARNING LETTER FLA-14-14, DATED JUNE 2, 2014, AND PURSUANT TO THE PROVISIONS OF 21 CFR PART 803.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE UNITED STATES THAT THE PATIENT ((B)(6), MALE) WAS TAKEN TO A LOCAL HOSPITAL BY EMERGENCY MEDICAL SERVICE (EMS) ON (B)(6) 2014 DUE TO WEAKNESS AND INCONTINENCE. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO WAS 3.13 AND THE EMERGENCY ROOM (ER) PHYSICIAN DID NOT BELIEVE THE PATIENT HAD SUFFERED FROM A STROKE. THE PATIENT WAS TRANSPORTED TO THE IMPLANTING HOSPITAL BUT EN ROUTE BECAME UNRESPONSIVE AND HAD AGONAL BREATHING. UPON ARRIVAL HE WAS INTUBATED DUE TO RESPIRATORY DISTRESS. A COMPUTED TOMOGRAPHY (CT) SCAN SHOWED AN EXTENSIVE INTRACRANIAL HEMORRHAGE INCLUDING A LARGE PARENCHYMAL HEMORRHAGE OF ABOUT 6 X 4.7 CM CENTERED IN THE FRONTAL LOBE WITH AN APPROXIMATE 1.1 CM RIGHT TO LEFT SHIFT OF THE MIDLINE LEVEL OF THE SEPTUM PELLUCIDUM. THERE WAS SURROUNDING VASOGENIC EDEMA, HYDROCEPHALUS, AND ALSO A SMALLER AMOUNT OF SUBARACHNOID HEMORRHAGE. THE PATIENT WAS GIVEN 4 UNITS OF FRESH FROZEN PLASMA (FFP) BUT BECAUSE OF THE EXTENSIVE HEMORRHAGE, THE NEUROSURGERY DEPARTMENT DID NOT FEEL THAT SURGICAL INTERVENTION WOULD BE BENEFICIAL. ON (B)(6) 2014, THE PATIENT'S PUPILS WERE NOTED TO BE FIXED AND DILATED, AND THE PATIENT BEGAN NON-PURPOSEFUL TWITCHING. THE FAMILY DECIDED TO WITHDRAW CARE. WHEN THE PATIENT'S PACER/AUTOMATIC IMPLANTABLE CARDIOVERTER-DEFIBRILLATOR (AICD) WAS TURNED OFF, THERE WAS NO UNDERLYING CARDIAC RHYTHM AND THE PATIENT WAS PRONOUNCED DEAD. THE PUMP WAS TURNED OFF POST-MORTEM. BLOOD CULTURES HAD BEEN DRAWN ON (B)(6) 2014 BUT RESULTS WERE NOT AVAILABLE UNTIL AFTER THE PATIENT'S DEATH; THE BLOOD CULTURES WERE POSITIVE FOR STREPTOCOCCUS MITIS. THE PUMP WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AND REMAINED IMPLANTED IN THE PATIENT. THE PERIPHERAL EQUIPMENT, EXCLUDING ONE BATTERY, WAS RETURNED TO THE MANUFACTURER FOR ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    191335 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Death (B)(4)_BATTERY