BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2931722 · Received January 28, 2013

    Report

    Report Number
    3007042319-2013-00003
    Event Type
    Death
    Date Received
    January 28, 2013
    Date of Event
    December 28, 2012
    Report Date
    December 30, 2012
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PRODUCT REMAINS IMPLANTED IN THE PATIENT, THEREFORE IT WILL NOT BE RETURNED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. (B)(4): DEVICE REMAINS IMPLANTED IN PATIENT.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT EXPERIENCED AN EMBOLIC CVA AND SUBSEQUENTLY EXPIRED AFTER THE FAMILY DECIDED TO WITHDRAW CARE. THE HVAD PUMP ((B)(4)) WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINED IMPLANTED POSTMORTEM. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES REVEAL MULTIPLE SUCTION ALARMS; HOWEVER, VAD PARAMETERS WERE WITHIN NORMAL OPERATING RANGE. STROKE/NEUROLOGICAL DYSFUNCTION AND DEATH ARE KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). A USER MUST FULLY CONSIDER THE RISKS OF THIS DEVICE WITH THAT OF OTHER TREATMENT MODALITIES BEFORE DECIDING TO PROCEED WITH DEVICE IMPLANTATION. THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT INCLUDING MEDICAL MANAGEMENT AND THERAPEUTIC ANTICOAGULATION GUIDELINES TO MINIMIZE THE RISKS. ALTHOUGH A DEFINITIVE ROOT CAUSE AND RELATIONSHIP TO THE DEVICE CANNOT BE DETERMINED, CLINICAL STATUS, COMORBIDITIES, AND PHARMACOLOGICAL FACTORS ARE POSSIBLE CONTRIBUTING FACTORS. 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. PER THE INSTRUCTIONS FOR USE (IFU):ADVERSE EVENTS THAT MAY BE ASSOCIATED WITH THE USE OF VENTRICULAR ASSIST DEVICES, OTHER THAN DEATH, INCLUDE STROKE. 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.

    Additional Manufacturer Narrative · 1

    DEVICE REMAINS IMPLANTED IN PATIENT.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED AN ISCHEMIC AND HEMORRHAGIC CVA POST HEARTWARE LVAD IMPLANTATION APPROXIMATELY NINE AND A HALF MONTHS AFTER THE IMPLANTATION. THE PATIENT WAS FOUND UNRESPONSIVE AT HOME BY HER FAMILY. THE PATIENT WAS ADMITTED TO THE HOSPITAL UNRESPONSIVE. THOUGH THE INITIAL CT WAS NORMAL, A SUBSEQUENT ONE REVEALED RIGHT MIDDLE CEREBRAL ARTERY INFARCT WITH SUBARACHNOID HEMORRHAGE. A DECISION WAS MADE TO WITHDRAW SUPPORT AND THE PATIENT EXPIRED SIX DAYS AFTER THE ONSET OF THIS EVENT. THE PATIENT'S PHYSICIAN REPORTED THAT THIS EVENT WAS AN EMBOLIC CVA AND WAS FELT TO BE RELATED TO THE HEARTWARE DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    36380 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Death| L| S