BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HEARTWARE® VENTRICULAR ASSIST SYSTEM

    MDR report key: 3214066 · Received July 9, 2013

    Report

    Report Number
    3007042319-2013-00074
    Event Type
    Malfunction
    Date Received
    July 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 15, 2013
    Manufacturer
    HEARTWARE, INC
    Product Code
    DSQ
    PMA / PMN Number
    P100047
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN THIRTY (30) DAYS OF RECEIPT. (B)(4).

    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. THIS INCLUDED CLINICAL EVALUATION, REVIEW OF MANUFACTURING DOCUMENTATION, LABELING AND INSTRUCTIONS FOR USE, VISUAL AND FUNCTIONAL EXAMINATION, INDEPENDENT PATHOLOGY ANALYSIS AND REVIEW OF CONTROLLER LOG FILES. THE REPORTED EVENT OF HIGH POWER WAS CONFIRMED VIA REVIEW OF THE CONTROLLER LOG FILES AND IS LIKELY RELATED TO THE THROMBUS FOUND GROSSLY WITHIN THE PUMP ON PATHOLOGICAL ANALYSIS (ALTHOUGH THIS FINDING WAS NOT ABLE TO BE CONFIRMED WITH HISTOLOGY). THE ORIGIN OF THIS THROMBUS CANNOT BE CONCLUSIVELY DETERMINED. CLINICAL FACTORS THAT MAY HAVE CONTRIBUTED TO THIS EVENT INCLUDE THE PATIENT'S HISTORY OF STROKE, WORSENING RENAL AND HEPATIC FAILURE, WORSENING RIGHT VENTRICULAR FAILURE AND HIS SUB-OPTIMAL ANTICOAGULATION AT THE TIME OF THE EVENT. REVIEW OF THE MANUFACTURING DOCUMENTATION CONFIRMED THAT HW3392 MET ALL REQUIREMENTS FOR RELEASE. POST EXPLANT ENGINEERING EVALUATION DID NOT REVEAL ANY CONDITIONS THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. BASED ON THE INFORMATION PROVIDED, THERE IS NO EVIDENCE TO SUGGEST THAT THE REPORTED EVENT RELATES TO A DEVICE DEFECT. NO ADDITIONAL INFORMATION WILL BE FORTHCOMING.

    Description of Event or Problem · 1

    THIS EVENT INVOLVED A PATIENT, WHO EXPERIENCED A HIGH POWER EVENT APPROXIMATELY 4 MONTHS AFTER THE IMPLANTATION. THE PATIENT WAS ADMITTED TO THE HOSPITAL WITH HIGH POWER ALARMS, INR OF 1.8, DARK URINE AND HIGH CREATININE. THE PATIENT WAS REPORTED TO BE ON ASPIRIN AND COUMADIN TREATMENT. THE SITE STATED THAT THE PATIENT WAS PLACED ON HEPARIN, AND THAT THROMBOLYTIC THERAPY WAS NOT CONSIDERED DUE TO THE PATIENT¿S HISTORY OF STOKE. THEREFORE, THE PATIENT WAS SENT TO THE OPERATING ROOM (OR) AND UNDERWENT A PUMP EXCHANGE. AS PER CLINICAL STAFF, PATIENT WAS PLACED ON ECMO AND WAS SUFFERING MULTIPLE SYSTEM ORGAN FAILURE. THE PRODUCT HAS BEEN RETURNED TO HEARTWARE FOR FURTHER ANALYSIS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    313811 HEARTWARE® VENTRICULAR ASSIST SYSTEM CIRCULATORY ASSIST SYSTEM DSQ HEARTWARE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| L| R CONTROLLER ((B)(4))