BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 6087179 · Received November 8, 2016

    Report

    Report Number
    3007042319-2016-03903
    Event Type
    Injury
    Date Received
    November 8, 2016
    Date of Event
    May 24, 2014
    Report Date
    May 28, 2014
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE HEARTWARE VAD IS USED FOR TREATMENT NOT DIAGNOSIS. THE DEVICE (B)(4) WAS RETURNED TO THE MANUFACTURER FOR EVALUATION. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT (B)(4) MET ALL REQUIREMENTS FOR RELEASE. THE REPORTED EVENT COULD NOT BE CONFIRMED VIA FUNCTIONAL TESTING OR REVIEW OF THE CONTROLLER LOG FILES, SINCE LOGS COVERING THE EVENT DATE WERE NOT AVAILABLE FOR ANALYSIS. DURING VISUAL INSPECTION, SCORING ON THE INFERIOR IMPELLER SURFACE AND THE CERAMIC SURFACE ON THE LOWER HOUSING WAS OBSERVED. THESE MARKS ARE INDICATIVE THAT A KNOWN EXTERNAL FACTOR, SUCH AS THROMBUS, WHICH WAS CONFIRMED THROUGH HISTOLOGICAL EVALUATION, MAY HAVE FORCED THE IMPELLER AGAINST THE REAR HOUSING. THIS CONDITION MAY HAVE LIMITED THE PERFORMANCE OF THE DEVICE AND POTENTIALLY TRIGGERED AN INCREASE IN POWER CONSUMPTION. POST-EXPLANT EVALUATION REVEALED THE EXAMINED ADHERENT MATERIALS WERE GROSSLY AND HISTOLOGICALLY CONSISTENT WITH THROMBI. THE DEVICE MALFUNCTION WAS UNCONFIRMED; THERE IS NO EVIDENCE TO SUGGEST THAT THE DEVICE CAUSED OR CONTRIBUTED TO THE REPORTED EVENT. THE MOST PROBABLE ROOT CAUSE OF THE REPORTED EVENT MAY BE ATTRIBUTED TO THROMBUS FORMATION/INGESTION WITHIN THE DEVICE. THROMBUS IS A KNOWN RISK ASSOCIATED WITH USE OF VENTRICULAR ASSIST DEVICES NOTED WITHIN THE LABELING. 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. HIGH WATTS ALARMS, AN INDICATION THAT THE PUMP WATTS HAS EXCEEDED THE HIGH POWER ALARM THRESHOLD, MAY BE INDICATIVE OF THROMBUS OR OTHER TISSUE FRAGMENTS IN THE PUMP. THROMBUS IS A KNOWN POTENTIAL COMPLICATION ASSOCIATED WITH ALL PATIENTS IMPLANTED WITH VADS AS OUTLINED IN THE LABELING. THE INSTRUCTIONS FOR USE ADDRESSES SETTING PARAMETERS FOR THE HIGH POWER ALARM THRESHOLD, HOW TO RECOGNIZE HIGH WATT ALARMS AND GUIDELINES FOR OPTIMAL PATIENT MANAGEMENT (INCLUDING THERAPEUTIC ANTICOAGULATION GUIDELINES). 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.

    Description of Event or Problem · 1

    IT WAS REPORTED FROM THE UNITED STATES THAT THE PATIENT WAS ADMITTED TO THE HOSPITAL ON (B)(6) 2014 FOR DARK COLORED URINE AND HEMOLYSIS. THE PATIENT'S INTERNATIONAL NORMALIZED RATIO (INR) WAS 2.1 AT EVENT ONSET AND HIGH PLASMA FREE HEMOGLOBIN WAS MEASURED ON (B)(6) 2014. PUMP PARAMETERS WERE ABOVE THE NORMAL OPERATING RANGE WITH POWER CONSUMPTION > 11 WATTS AND ESTIMATED PUMP FLOW > 9 L/MIN AT A PUMP SPEED OF 3260 RPM. THE PATIENT'S COUMADIN WAS WITHHELD ON (B)(6) 2014 AND A PUMP EXCHANGE WAS PERFORMED ON (B)(6) 2014. THE PATIENT WAS DISCHARGED HOME ON (B)(6) 2014. THE DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    738783 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R