BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3971429 · Received July 31, 2014

    Report

    Report Number
    3007042319-2014-00781
    Event Type
    Malfunction
    Date Received
    July 31, 2014
    Date of Event
    June 22, 2014
    Report Date
    July 1, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD IS USED FOR TREATMENT NOT DIAGNOSIS. IT WAS REPORTED THAT THE PATIENT DEVELOPED 'HIGH WATT' ALARMS AND HIGH PUMP FLOW. HE WAS TREATED WITH ENOXAPARIN FOR A SUB-THERAPEUTIC INR, PUMP SPEED WAS DECREASED AND THE 'HIGH WATT' ALARM LIMIT INCREASED. HIGH PUMP FLOWS PERSISTED AND CLOPIDOGREL WAS COMMENCED. IT WAS LAST REPORTED THAT THE PATIENT WAS DOING WELL WITH PUMP PARAMETERS BACK TO BASELINE. THE PUMP ((B)(4)) WAS NOT RETURNED TO MANUFACTURER FOR EVALUATION AS IT REMAINS IMPLANTED. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT THE PUMP ((B)(4)) MET ALL REQUIREMENTS FOR RELEASE. REVIEW OF THE CONTROLLER LOG FILES CONFIRMED REPORTED ELEVATED POWER CONSUMPTION AS WELL AS "HIGH WATTS" ALARMS. THE ROOT CAUSE OF THE REPORTED "HIGH WATTS" CANNOT BE CONCLUSIVELY DETERMINED, HOWEVER, A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THROMBUS FORMATION/INGESTION WITHIN THE DEVICE. ADDITIONALLY, THERE ARE PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT. 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

    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 TWO MONTHS AFTER IMPLANT, THIS PATIENT DEVELOPED HIGH WATTS ALARMS AND HIGH PUMP FLOW. HE COMPLAINED OF HAVING FELT GENERALLY UNWELL AND FATIGUED IN THE DAYS PRIOR. HE WAS TREATED WITH ENOXAPARIN FOR A SUBTHERAPEUTIC INR, PUMP SPEED WAS DECREASED AND THE HIGH WATTS ALARM LIMIT INCREASED. APPROXIMATELY TEN DAYS LATER, HIGH PUMP FLOWS PERSISTED AND CLOPIDOGREL WAS COMMENCED FOR POSSIBLE PUMP THROMBOSIS. HE WAS MONITORED THEREAFTER AND ON LAST REPORT WAS DOING WELL WITH PUMP PARAMETERS BACK TO BASELINE. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    447094 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 63 YR Hospitalization| L| R WARFARIN