BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3771145 · Received April 24, 2014

    Report

    Report Number
    3007042319-2014-00382
    Event Type
    Death
    Date Received
    April 24, 2014
    Date of Event
    March 21, 2014
    Report Date
    March 25, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT A PATIENT EXPERIENCED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT IN THE ICU FOLLOWING LVAD IMPLANTATION. A COMPUTERIZED TOMOGRAPHY (CT) SCAN WAS PERFORMED TO ACCESS THE SEVERITY OF THE BLEED. IT WAS REPORTED THAT CARE WAS WITHDRAWN BY THE FAMILY DUE TO POOR PROGNOSIS. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. DEATH AND SERIOUS, LIFE-THREATENING ADVERSE EVENTS, INCLUDING STROKE AND BLEEDING, HAVE BEEN ASSOCIATED WITH THE USE OF THIS DEVICE 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. 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

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

    Description of Event or Problem · 1

    APPROXIMATELY THREE WEEKS POST HVAD IMPLANTATION; THE PATIENT REMAINED IN THE HOSPITAL ON VENOVENOUS EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) SECONDARY TO POSTOPERATIVE RESPIRATORY FAILURE. THE PATIENT REMAINED ON ECMO FOR MORE THAN A WEEK AND WAS REPORTED TO HAVE "NEVER REALLY WOKEN UP POST-OPERATIVELY." A COMPUTERIZED TOMOGRAPHY (CT) SCAN OF THE HEAD REVEALED A LEFT OCCIPITAL-PARIETAL AND TEMPORAL HEMORRHAGIC CEREBRAL VASCULAR ACCIDENT (HCVA). THE SITE REPORTED THAT THE STROKE WAS THOUGHT TO BE RELATED TO THE EXTENDED PERIOD OF TIME THE PATIENT WAS ON ECMO AND NOT THE HVAD. THE PATIENT WAS REPORTED TO HAVE A POOR PROGNOSIS AND THE FAMILY MADE THE DECISION TO WITHDRAW SUPPORT. THE PATIENT EXPIRED JUST LESS THAN ONE MONTH AFTER IMPLANTATION. THE FAMILY DECLINED TO HAVE AN AUTOPSY PERFORMED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    250138 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Death