BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 2983071 · Received February 28, 2013

    Report

    Report Number
    3007042319-2013-00026
    Event Type
    Injury
    Date Received
    February 28, 2013
    Date of Event
    December 5, 2012
    Report Date
    January 31, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    THE PRODUCT WAS RETURNED; VARIOUS ANALYSES WERE CONDUCTED AND REVIEWED IN ORDER TO EVALUATE THE PERFORMANCE OF THE LVAD PUMP IN RELATION TO THE REPORTED EVENT. THESE INCLUDED, BUT WERE NOT LIMITED TO, CLINICAL EVALUATION, REVIEW OF MANUFACTURING DOCUMENTATION, LABELING AND INSTRUCTIONS FOR USE, VISUAL AND FUNCTIONAL EXAMINATION, INDEPENDENT PATHOLOGY ANALYSIS. THE INDEPENDENT PATHOLOGICAL ANALYSIS CONFIRMED THE PRESENCE OF THROMBUS WITHIN THE DEVICE. WHILE THE EXACT CAUSE COULD NOT BE DETERMINED, CLINICAL FACTORS INDICATED THAT WHAT MAY HAVE CONTRIBUTED TO THE EVENT INCLUDES THE PATIENT'S SUB-OPTIMAL ANTI-COAGULATION AND INR BELOW THE THERAPEUTIC RANGE. BASED ON REVIEW OF THE AVAILABLE INFORMATION, THE REPORTED EVENT (HIGH POWER) COULD NOT BE CONFIRMED BECAUSE NO CONTROLLER LOG FILES WERE AVAILABLE FOR HW2725. THERE IS NO EVIDENCE TO SUGGEST A DEVICE MALFUNCTION AS THE CAUSE THAT LED TO THE REPORTED EVENT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT WHO EXPERIENCED A PUMP EXCHANGE DUE TO A HIGH POWER EVENT APPROXIMATELY TEN MONTHS POST HEARTWARE LVAD IMPLANTATION. ADDITIONAL INVESTIGATION IS ON-GOING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    86099 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening