BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6081598 · Received November 7, 2016

    Report

    Report Number
    3007042319-2016-03892
    Event Type
    Injury
    Date Received
    November 7, 2016
    Date of Event
    June 14, 2013
    Report Date
    June 17, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HVAD PUMP ((B)(4)) WAS RETURNED TO MANUFACTURER FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT PUMP ((B)(4)) MET ALL REQUIREMENTS FOR RELEASE. POST-EXPLANT ENGINEERING EVALUATION DID NOT REVEAL ANY CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. THE REPORTED INADEQUATE FLOW RATE EVENT WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES. THE LOW FLOW EVENT COULD HAVE BEEN A RESULT OF THE TISSUE AT THE LVAD INFLOW CANNULA THAT WAS VISUALIZED DURING EXPLANT. INDEPENDENT PATHOLOGICAL ANALYSIS CONFIRMED THE PRESENCE OF WELL-ORGANIZED THROMBUS AT THE INFLOW CANNULA. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT CAN BE ATTRIBUTED TO THROMBUS FORMATION WITHIN THE DEVICE; HOWEVER, THERE ARE PATIENT, PROCEDURAL AND PHARMACOLOGICAL FACTORS WHICH INCLUDE THE PATIENT'S HISTORY, ONGOING ARRHYTHMIAS AND HIS RECURRENT INFECTIONS AND SEPSIS THAT MAY HAVE CONTRIBUTED TO THE INADEQUATE FLOW 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, INCLUDING TRANSPORTATION. THE PUMP IS A FIXED SPEED SYSTEM. LOW FLOW, AVERAGE FLOW BELOW THE ALARM THRESHOLD, MAY BE RELATED TO POOR VAD FILLING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING OF PARAMETERS FOR FLOW, POWER AND WATTS. GUIDELINES FOR POTENTIAL CAUSES OF ALARMS, ASSESSMENT OF THE PATIENT AND DEVICE STATUS ALONG WITH RELATED POTENTIAL CAUSES WHICH CAN INCLUDE RIGHT VENTRICULAR FAILURE, HYPOVOLEMIA, TAMPONADE, ARRHYTHMIAS, HIGH BLOOD PRESSURE, INFLOW CANNULA OBSTRUCTION, OUTFLOW GRAFT KINK ARE OUTLINED ALONG WITH POTENTIAL ACTIONS TO TAKE. HEARTWARE IS SUBMITTING THIS CORRECTION TO A PREVIOUSLY SUBMITTED MDR 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. (B)(4).

    Description of Event or Problem · 1

    APPROXIMATELY NINETEEN AND A HALF MONTHS AFTER THE IMPLANTATION, THE PATIENT NOTED THAT THE FLOW ON HIS LVAD ((B)(4)) WAS READING A NEGATIVE NUMBER. THE SITE REPORTED THAT THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS THERAPEUTIC AT THE TIME OF THE EVENT. EMERGENCY RESPONSE ASSISTED THE PATIENT IN CHANGING HIS CONTROLLER, TRANSPORTED HIM TO THE HOSPITAL AND REPORTED THAT HE HAD A GOOD PULSE AND BLOOD PRESSURE. THE PATIENT WAS TRANSFERRED TO THE INTENSIVE CARE UNIT AND WAS INITIALLY TREATED WITH HEPARIN. THREE DAYS AFTER THE INITIAL ONSET OF THE PATIENT'S SYMPTOMS, HE UNDERWENT PUMP EXCHANGE (FOR (B)(4)). DURING THE EXCHANGE, THE SURGEON VISUALIZED LEFT VENTRICULAR THROMBUS WHICH WAS EXCISED AND FOUND TISSUE ON THE INFLOW CANNULA OF THE EXPLANTED PUMP. IT APPEARS THAT THE SURGERY WAS OTHERWISE UNEVENTFUL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    732788 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R