BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3971291 · Received July 31, 2014

    Report

    Report Number
    3007042319-2014-00793
    Event Type
    Injury
    Date Received
    July 31, 2014
    Date of Event
    July 2, 2014
    Report Date
    July 4, 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

    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 EXPERIENCED LOW FLOWS AND A TRANSIENT ISCHEMIC ATTACK. THE COMPUTERIZED TOMOGRAPHY (CT) SCAN PERFORMED BY THE SITE REVEALED THAT THE INFLOW CANNULA WAS NOT OPTIMALLY POSITIONED AND MAY HAVE BEEN PARTIALLY BLOCKED BY THE INTERVENTRICULAR SEPTUM. PATIENT WAS MEDICALLY MANAGED BY MONITORING FLUID STATUS, TREATMENT OF ARRHYTHMIAS AND BY ADJUSTING PUMP FLOWS AND HEMATOCRIT LEVELS UNTIL THE ALARMS EVENTUALLY STOPPED. IT WAS LAST REPORTED THAT THE PATIENT WAS DISCHARGED FROM THE HOSPITAL. THE DEVICE, (B)(4), WAS NOT RETURNED TO THE MANUFACTURER FOR EVALUATION AS IT REMAINED IMPLANTED; 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' ALARMS. A POSSIBLE ROOT CAUSE OF THE INADEQUATE FLOW RATE EVENT MAY BE ATTRIBUTED TO INCORRECT PLACEMENT OF THE PUMP; HOWEVER, 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. STROKE AND NEUROLOGICAL DYSFUNCTION ARE KNOWN POTENTIAL CLINICAL ADVERSE EVENT ASSOCIATED WITH VADS AS OUTLINED IN THE IFU. EVENTS OF THESE TYPES ARE MULTIFACTORIAL AND MAY BE ATTRIBUTED TO PRE-EXISTING CONDITIONS AND PROGRESSION OF THESE DISEASES, THE HVAD SYSTEM, THE IMPLANT PROCEDURE, OR CONCOMITANT THERAPY. 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 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 SIX MONTHS POST IMPLANTATION, THE PATIENT WAS ADMITTED TO HOSPITAL'S CARDIAC UNIT AFTER EXPERIENCING PERSISTENT LOW FLOW ALARMS AND A TRANSIENT ISCHEMIC ATTACK (TIA) WHICH PROGRESSED INTO AN ISCHEMIC CEREBROVASCULAR ACCIDENT (ICVA). THE PATIENT'S BLOOD PRESSURE WAS WITHIN NORMAL LIMITS DURING THIS TIME. ECHOCARDIOGRAM RESULTS REVEALED A PARTIALLY FILLED LEFT VENTRICLE AND CT SCAN RESULTS REVEALED THAT THE INFLOW CANNULA WAS NOT OPTIMALLY POSITIONED AND MAY HAVE BEEN PARTIALLY BLOCKED BY THE INTERVENTRICULAR SEPTUM. THE PATIENT CONTINUED TO EXPERIENCE LOW FLOW AND SUCTION ALARMS THROUGHOUT THEIR HOSPITAL STAY WHICH WERE MANAGED BY MONITORING FLUID STATUS, TREATMENT OF ARRHYTHMIAS, AND PERIODIC ADJUSTMENTS OF PUMP FLOWS. HE WAS DISCHARGED HOME SEVENTEEN DAYS AFTER HIS ADMISSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    446537 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Hospitalization| L| R