BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3800388 · Received May 8, 2014

    Report

    Report Number
    3007042319-2014-00429
    Event Type
    Malfunction
    Date Received
    May 8, 2014
    Date of Event
    April 8, 2014
    Report Date
    April 8, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    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 THE PATIENT WAS ADMITTED TO THE HOSPITAL AFTER AN ACUTE DROP IN FLOWS AND POWER. THE PATIENT WAS STARTED ON HEPARIN AND INTEGRILIN INFUSIONS FOR TREATMENT OF SUSPECTED OUTFLOW GRAFT THROMBUS. THE PATIENT WAS TRANSPLANTED A MONTH LATER. THE OUTFLOW GRAFT WAS NOT RETURNED FOR EVALUATION, THEREFORE TESTING COULD NOT BE PERFORMED. REVIEW OF THE MANUFACTURING DOCUMENTATION REVEALED UNIT MET ALL INTERNAL REQUIREMENTS PRIOR TO ITS QUALITY ASSURANCE RELEASE; THEREFORE THERE IS NO EVIDENCE THAT THE MANUFACTURING PROCESS WAS A CONTRIBUTORY FACTOR. REVIEW OF THE CONTROLLER LOG FILES REVEALED ONE 'LOW FLOW' ALARM AND A DECREASE IN POWER CONSUMPTION; TRENDS OF THIS NATURE MAY BE INDICATIVE OF AN OCCLUSION EVENT. THE ROOT CAUSE OF THE REPORTED EVENT COULD NOT BE CONCLUSIVELY DETERMINED; HOWEVER, A POSSIBLE ROOT CAUSE MAY BE ATTRIBUTED TO THE SUSPECTED OUTFLOW GRAFT THROMBUS AS DESCRIBED IN THE EVENT DETAILS. 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.

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION RECEIVED INDICATED THAT CT SCAN AND ECHO RESULTS FAILED TO SHOW ANY EVIDENCE OF THROMBUS OR OUTFLOW GRAFT KINKING, THE SITE HAD REPORTED DIFFICULTY MAINTAINING THE PATIENT'S INR IN THERAPEUTIC RANGE. PUMP POWER AND FLOWS STARTED TO INCREASE BUT VITAL SIGNS REMAINED STABLE. ABOUT A WEEK LATER HEPARIN AND INTEGRILLIN WERE REPLACED WITH ARGATROBAN DUE TO SUSPECTED HEPARIN INDUCED THROMBOCYTOPENIA. ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS TRANSPLANTED APPROXIMATELY ONE MONTH LATER. THE EXPLANTED PUMP WILL NOT BE RETURNED TO THE MANUFACTURER BECAUSE IT WAS RETAINED BY THE SITE. INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    APPROXIMATELY SIX MONTHS POST HVAD IMPLANT, THE PATIENT PRESENTED TO THE HOSPITAL AFTER HAVING AN ACUTE AND SUSTAINED DECREASE IN ESTIMATED VAD FLOW WITH A CORRESPONDING ELEVATION IN THE INTERNATIONAL NORMALIZED RATIO (INR) AND LACTATE DEHYDROGENASE (LDH).THE PATIENT WAS STARTED ON A HEPARIN DRIP FOR A POTENTIAL OUTFLOW GRAFT OCCLUSION DUE TO THROMBUS. DETAILS REGARDING FURTHER TESTING, TREATMENT AND STATUS OF PATIENT WERE NOT PROVIDED. ADDITIONAL INFORMATION HAS BEEN REQUESTED. INVESTIGATION IS ONGOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277118 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 39 YR Hospitalization| L| R