BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3122090 · Received May 16, 2013

    Report

    Report Number
    2916596-2013-00618
    Event Type
    Injury
    Date Received
    May 16, 2013
    Date of Event
    April 17, 2013
    Report Date
    April 17, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ONGOING WITH THE NEWLY IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. THE 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 MANUFACTURER'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    THE PATIENT WAS IMPLANTED WITH A LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE SURGEON REPORTED, THE PATIENT EXPERIENCED POWER SPIKES. THE PATIENT THEN HAD A CHANGE IN MENTAL STATUS. THE PATIENT WAS TRANSFERRED TO ICU AND REQUIRED INTUBATION TO PROTECT AIRWAY. CT SCAN OF HEAD SHOWED NO BLEED. PATIENT WAS TAKEN TO ICU WHERE A LINE WAS PLACED WITH PULSATILE AND HAS PERIPHERAL PULSES. PATIENT BOLUSED AND HEPARINIZED, AN ECHO SHOWED MINIMAL MITRAL REGURGITATION, RAMP STUDY ATTEMPTED AND COULD NOT REALLY SHRINK THE LEFT VENTRICLE. PATIENT THEN STARTED TO HAVE ALARMS, LOW FLOW, AND PUMP OFF. THE SURGEON NOTED LOW SPEED AND VAD AUSCULTATION WAS ABNORMAL. THE PATIENT WAS TAKEN TO THE OPERATING ROOM AND THE ENTIRE PUMP FROM INFLOW TO OUTFLOW CANNULA COMPLETELY CLOTTED. THE PATIENT RECEIVED A PUMP EXCHANGE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    216704 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE DSQ: LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 125085

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention