BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3973645 · Received August 1, 2014

    Report

    Report Number
    3007042319-2014-00799
    Event Type
    Death
    Date Received
    August 1, 2014
    Date of Event
    June 26, 2014
    Report Date
    July 3, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    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. PRODUCT BURIED WITH PATIENT.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT SUFFERED A HEMORRHAGIC STROKE. THE PATIENT WAS ADMITTED TO THE HOSPITAL AND UNDERWENT AN EMERGENT CRANIOTOMY AND PLACEMENT OF VENTRICULAR DRAIN. IT WAS REPORTED THAT THE FAMILY WITHDREW SUPPORT AND THE PATIENT EXPIRED IN THE HOSPITAL. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. SERIOUS AND LIFE THREATENING ADVERSE EVENTS INCLUDING DEATH, BLEEDING, AND STROKE HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE INCLUDING NEUROLOGICAL DYSFUNCTION, STROKE AND BLEEDING 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. HEMORRHAGIC TRANSFORMATION IS A KNOWN MULTIFACTORIAL PHENOMENON IN WHICH ISCHEMIC BRAIN TISSUE CONVERTS INTO A HEMORRHAGIC LESION DUE TO LOSS OF MICROVASCULAR INTEGRITY WITH BLOOD-VESSEL LEAKAGE, EXTRAVASATION AND FURTHER BRAIN INJURY. 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. HEARTWARE WILL SUBMIT A SUPPLEMENTAL REPORT WHEN NEW FACTS ARISES WHICH MATERIALLY ALTERS INFORMATION SUBMITTED IN A PREVIOUS MDR REPORT.

    Description of Event or Problem · 1

    SEVEN MONTHS POST HVAD IMPLANTATION THE PATIENT REPORTED TO A NEARBY HOSPITAL AFTER EXPERIENCING HEADACHE, NAUSEA, AND VOMITING. A CT SCAN OF THE HEAD REVEALED A LEFT SUBDURAL HEMORRHAGE. THE PATIENT'S ANTICOAGULANT THERAPY WAS HELD AND HE WAS TAKEN TO THE OPERATING ROOM FOR CRANIOTOMY AND PLACEMENT OF AN EXTERNAL VENTRICULAR DRAIN (EVD). FOLLOW UP CT RESULTS INDICATED THAT HE HAD DEVELOPED INTRAPARENCHYMAL HEMORRHAGES OF THE LEFT ANTERIOR CEREBRAL ARTERY AND HYDROCEPHALUS ALONG WITH WORSENING NEUROLOGICAL EXAMS. SEVERAL DAYS LATER THE FAMILY MADE THE DECISION TO WITHDRAW CARE AND THE PATIENT SUBSEQUENTLY EXPIRED. THE PUMP REMAINS IMPLANTED IN THE PATIENT POST-MORTEM. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    449918 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death COUMADIN