BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3884123 · Received June 19, 2014

    Report

    Report Number
    3007042319-2014-00631
    Event Type
    Injury
    Date Received
    June 19, 2014
    Date of Event
    May 23, 2014
    Report Date
    May 23, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT WHILE HOSPITALIZED FOR RIGHT HEART FAILURE, THIS PATIENT EXPERIENCED HIGH POWER AND RECEIVED TREATMENT FOR SUSPECTED THROMBUS; SEVERAL DAYS LATER, PATIENT RECEIVED A HEART TRANSPLANT. THE DEVICE ((B)(4)) WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION; HOWEVER, REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE ASSOCIATED DEVICE MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES, WHICH REVEALED MULTIPLE 'LOW FLOW' AND 'HIGH WATTS' ALARMS. A CLINICAL FACTOR THAT MAY HAVE CONTRIBUTED TO THE REPORTED EVENT IS THE PATIENT'S RIGHT HEART FAILURE. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED 'HIGH POWER' EVENT MAY BE ATTRIBUTED TO THROMBUS FORMATION/INGESTION WITHIN THE DEVICE. 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. SERIOUS AND LIFE THREATENING ADVERSE EVENTS, INCLUDING DEVICE THROMBOSIS, HAVE BEEN ASSOCIATED WITH USE OF THIS DEVICE AS OUTLINED IN THE INSTRUCTIONS FOR USE (IFU). THE IFU ADDRESSES GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES OF INR BETWEEN 2.0 AND 3.0). WHILE THERE IS NO EVIDENCE BASED ON THE AVAILABLE INFORMATION, IT MAY BE POSSIBLE THAT THERE WERE SOME UNDERLYING HEALTH CONDITIONS THAT COULD HAVE PREDISPOSED THE PATIENT TO THIS EVENT. FROM ALL INDICATIONS THE DEVICE OPERATED WITHIN SPECIFICATIONS AND AS INTENDED WITH NO INDICATION OF ANY DEVICE PERFORMANCE ISSUES CONTRIBUTING TO THE EVENT. 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

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. DEVICE NOT RETURNED.

    Description of Event or Problem · 1

    APPROXIMATELY TWO MONTHS AND TWO AND A HALF WEEKS POST HVAD IMPLANTATION WHILE ALREADY ADMITTED TO THE HOSPITAL FOR TREATMENT OF RIGHT HEART FAILURE, THE VAD COORDINATOR NOTICED A RISE IN POWER CONSUMPTION ABOVE NORMAL PUMP PARAMETERS FOLLOWED BY HIGH PRIORITY ALARMS. PRELIMINARY LOG FILE ANALYSIS CONFIRM HIGH POWER ON THE DATE OF THE REPORTED EVENT. THE PATIENT WAS SUBSEQUENTLY ADMINISTERED TISSUE PLASMINOGEN ACTIVATOR (TPA).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    361591 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R