BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 2181376 · Received July 21, 2011

    Report

    Report Number
    2916596-2011-00303
    Event Type
    Injury
    Date Received
    July 21, 2011
    Date of Event
    June 23, 2011
    Report Date
    June 23, 2011
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE MFR IS ATTEMPTING TO ACQUIRE THE DEVICE FOR FURTHER EVALUATION. NO FURTHER INFO 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 PT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). IT WAS REPORTED BY THE VAD COORDINATOR THAT A LVAD PUMP EXCHANGE TOOK PLACE DUE TO THE PT EXPERIENCING HEMOLYSIS. IT WAS NOTED THAT BEFORE THE EXPLANT PROCEDURE, THE PUMP SETTINGS WERE AS FOLLOWS: 7 LPM, 9600 RPM'S, PI 5-6S, POWER 8-10 RANGE. THE ARTERIAL LINE SHOWED THE AORTIC VALVE WAS OPENING WITH EVERY BEAT AND ON ECHO THE LEFT VENTRICULAR WAS FULL AND DILATED. ONCE INSIDE THE CHEST, THE SURGEON REMOVED THE PUMP AND LEFT THE INFLOW CONDUIT AND THE OUTFLOW GRAFT AND ASSESSED FOR CLOT OR OBSTRUCTION. THERE APPEARED TO BE NONE. THE NEW PUMP WAS PLACED. THE SURGEON DE-AIRED THE PUMP AND TURNED IT ON. THE LVAD SETTINGS WERE NOTED AT 5.5 LPM, 9400 RPM'S. PI 3.4, POWER 6 WATTS AND THE AORTIC VALVE WAS OPENING EVERY 3-4 BEATS. THE SURGEON STATED THAT THE LEFT VENTRICULAR WAS NOW UNLOADING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE II LVAD LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 103695 104107

    Patients

    Seq Age Sex Outcome Treatment
    1 35 YR Required Intervention