BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAS, EUROPE

    MDR report key: 2896004 · Received January 2, 2013

    Report

    Report Number
    2916596-2012-01287
    Event Type
    Injury
    Date Received
    January 2, 2013
    Date of Event
    December 7, 2012
    Report Date
    December 7, 2012
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT WAS IMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE. THE EXPLANTED DEVICE WAS RETURNED TO THE MANUFACTURER FOR EVALUATION AND IS CURRENTLY BEING ANALYZED. NO FURTHER INFORMATION IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE DEVICE ANALYSIS IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). APPROXIMATELY 2 DAYS POST-IMPLANT, A THROMBUS WAS OBSERVED WITHIN THE PATIENT'S AORTIC ARCH. THE SYSTEM CONTROLLER WAS EXCHANGED FOR A POCKET CONTROLLER AND ULTIMATELY, THE PATIENT WAS SWITCHED BACK TO THE SYSTEM CONTROLLER. THE PUMP POWER BEGAN TO INCREASE AND APPROXIMATELY 5 HOURS LATER, IT HAD REACHED 20 WATTS AND THE PUMP STOPPED. THE PATIENT WAS IMPLANTED WITH A CENTRAL EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND REMAINED ON THIS SUPPORT FOR 3 DAYS WHILE THE LVAD WAS TURNED OFF. THE ECMO AND PUMP WERE EXPLANTED AND THE PATIENT WAS IMPLANTED WITH ANOTHER MANUFACTURER'S DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1367 HEARTMATE II LVAS, EUROPE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103693 115383

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention