BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVAS KIT, HM-II, EUROPEAN, EP

    MDR report key: 2000715 · Received February 16, 2011

    Report

    Report Number
    2916596-2011-00066
    Event Type
    Injury
    Date Received
    February 16, 2011
    Date of Event
    January 22, 2011
    Report Date
    January 22, 2011
    Manufacturer
    THORATEC CORPORATION
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON LVAD SUPPORT WITH THE REPLACEMENT PUMP AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE MANUFACTURER IS ATTEMPTING TO ACQUIRE THE EXPLANTED DEVICE FOR FURTHER EVALUATION. 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 DEVICE. APPROXIMATELY 2 MONTHS POST-IMPLANT, THE VAD COORDINATOR REPORTED THAT THE PATIENT HAD SHOWN AN INCREASE OF HEMOLYSE PARAMETERS SINCE IMPLANT. UPON EVALUATION, A VENTRICULAR SEPTICAL DEFECT (VSD) WAS FOUND. A RAMP STUDY REVEALED NO UNLOADING OF THE LEFT VENTRICLE WITH SPEEDS UP TO 11,000 RPM. AN ECHO SHOWED INGROWTH IN THE INLET CANNULA. A DECISION WAS MADE TO EXCHANGE THE PUMP. ONCE EXPLANTED, THE VAD TEAM OBSERVED A KINK IN THE OUTFLOW GRAFT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LVAS KIT, HM-II, EUROPEAN, EP VENTRICULAR ASSIST DEVICE DSQ THORATEC CORPORATION 103693

    Patients

    Seq Age Sex Outcome Treatment
    1 34 YR Required Intervention