BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 4122427 · Received September 18, 2014

    Report

    Report Number
    2916596-2014-01567
    Event Type
    Injury
    Date Received
    September 18, 2014
    Date of Event
    July 28, 2014
    Report Date
    August 21, 2014
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NL
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED PUMP FOR ANALYSIS. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST (LVAD). APPROXIMATELY 7 WEEKS POST-IMPLANT, IT WAS REPORTED THAT THE PATIENT WAS IN THE REHAB CENTER AND HAD A SUDDEN INCREASE IN LDH LEVELS. AFTER A FEW DAYS THE PATIENT'S LDH HAD TRIPLED AND WAS ADMITTED INTO THE HOSPITAL. THE PUMP POWER HAD A SLIGHT INCREASE; HOWEVER, IT WAS REPORTED THE ONLY SYMPTOMS THE PATIENT HAD WAS FATIGUE AND HER PHYSICAL ACTIVITY WAS NOT IMPROVED. THE AUSCULTATION OF THE PUMP WAS REPORTED TO BE FINE. AN ECHOCARDIOGRAM INDICATED A 'VERY BAD RIGHT VENTRICLE" AND A RAMP STUDY INDICATED LVEDD SLOPE - 0.06. PUMP THROMBOSIS WAS SUSPECTED AND THE HOSPITAL STARTED THE PATIENT ON AN IV HEPARIN DRIP. DUE TO THE PATIENT'S POOR RIGHT VENTRICLE FUNCTION THE PATIENT WAS GIVEN DIURETICS, THE PUMP SPEED WAS DECREASED AND THE PUMP POWER WAS RETURNED TO A NORMAL RANGE. THE PATIENT WAS PLACED ON THE URGENT TRANSPLANT LIST AND WAS TRANSPLANTED ON (B)(6) 2014.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    579287 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 106016 132526

    Patients

    Seq Age Sex Outcome Treatment
    1 45 YR Required Intervention