BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 3925544 · Received June 18, 2014

    Report

    Report Number
    2916596-2014-00876
    Event Type
    Injury
    Date Received
    June 18, 2014
    Date of Event
    April 9, 2014
    Report Date
    May 21, 2014
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    EVENT DATE HAS BEEN ESTIMATED. THE PT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP. THE MFR IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROX 4 MONTHS POST-IMPLANT IT WAS REPORTED THAT THE PT WAS ADMITTED INTO A LOCAL HOSPITAL DUE TO GI BLEEDING AND THE PHYSICIAN STOPPED THE PT'S ANTICOAGULATION. ON (B)(6) 2014, THE PT HAD COLLAPSED AND THE PT'S EVENT HISTORY INDICATED LOW FLOW ALARMS. ON (B)(6) 2014, THE PT HAD SIGNS OF HEMOLYSIS, ELEVATED LDH AND ELEVATED PLASMA FREE HEMOGLOBIN. AN ECHOCARDIOGRAM WAS PERFORMED AND INDICATED A DILATED LEFT VENTRICLE AND THE AORTIC VALVE OPENED WITH EVERY BEAT. APPROX 2 DAYS LATER, THE PUMP WAS EXCHANGED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    356832 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 106016 134288

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention