BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3771146 · Received April 24, 2014

    Report

    Report Number
    3007042319-2014-00387
    Event Type
    Injury
    Date Received
    April 24, 2014
    Date of Event
    March 27, 2014
    Report Date
    March 27, 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. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THIS PATIENT SUFFERED A HEMORRHAGIC CEREBROVASCULAR ACCIDENT (CVA). PATIENT UNDERWENT VENTRICULOSTOMY TO HAVE THE BLOOD DRAINED AND WAS REPORTED TO BE RECOVERING IN THE ICU. THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER FOR ANALYSIS AS IT REMAINS IMPLANTED. BLEEDING AND STROKE 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. 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.

    Description of Event or Problem · 1

    APPROXIMATELY EIGHT DAYS POST HVAD IMPLANTATION, WHILE STILL INTUBATED IN THE INTENSIVE CARE UNIT THE NURSING STAFF NOTICED A CHANGE IN THE PATIENT'S MENTATION AND ABILITY TO FOLLOW COMMANDS WHILE ON LIGHT SEDATION. ANTICOAGULATION THERAPY WAS HELD AND THE PATIENT WAS SUBSEQUENTLY TAKEN FOR A CT SCAN OF THE HEAD. RESULTS REVEALED A HETEROGENEOUS INTRAPARENCHYMAL HEMORRHAGE OF THE LEFT FRONTAL LOBE WITH INTRAVASCULAR CASTING AND ASSOCIATED HYDROCEPHALUS WITH RIGHTWARD MIDLINE SHIFT AND SUBFALCINE HERNIATION. NEUROSURGERY WAS CONSULTED AND ORDERED THE PATIENT TO HAVE A RIGHT, FRONT EXTERNAL VENTRICULAR DRAIN (EVD) PLACED. FOLLOW UP CT RESULTS PERFORMED OVER THE NEXT TWO DAYS REVEALED MINIMAL IMPROVEMENT OF THE INTRAPARENCHYMAL, SUBARACHNOID AND INTRAVENTRICULAR HEMORRHAGE, RIGHTWARD SHIFT FROM 8 TO 9 MM, AND A POSSIBLE AREA OF ISCHEMIC INJURY IN THE RIGHT PARIETAL LOBE. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT REMAINED IN THE INTENSIVE CARE UNIT FOR CONTINUED TREATMENT AND MEDICAL MANAGEMENT. THE PATIENT'S PROGNOSIS IS UNKNOWN AT THIS TIME. THIS EVENT IS BELIEVED TO BE RELATED TO THE HEARTWARE DEVICE BY THE TREATING PHYSICIAN. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249998 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Hospitalization| L| R HEPARIN| COUMADIN