BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LVAS KIT, HM-II, EUROPEAN, EP

    MDR report key: 1870928 · Received October 7, 2010

    Report

    Report Number
    2916596-2010-00253
    Event Type
    Injury
    Date Received
    October 7, 2010
    Date of Event
    September 9, 2010
    Report Date
    September 9, 2010
    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 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. APPROXIMATELY 6 MONTHS POST-IMPLANT, THE PATIENT COLLAPSED WHILE AT HOME, BUT WAS REPORTED TO HAVE SOON BECOME RESPONSIVE. A RED HEART ALARM HAD OCCURRED AND THE PATIENT WAS SYMPTOMATIC. THE AMBULANCE WAS CALLED AND THE PATIENT WAS TAKEN AND ADMITTED TO THE HOSPITAL. WHILE AT THE HOSPITAL, THE PATIENT BEGAN HAVING SYMPTOMS OF CARDIOGENIC SHOCK. AN ECHO DEMONSTRATED A DILATED LEFT VENTRICLE WITH POOR SYSTOLIC FUNCTION, BUT THE AORTIC VALVE WAS OPENING. THE RIGHT VENTRICLE WAS ALSO DILATED AND ALSO SHOWED POOR SYSTOLIC FUNCTION. HEPARINE AND DOPAMINE WERE STARTED. AN ECG SHOWED SINUS TACHYCARDIA. THE PATIENT REPORTED HE HAD NOT EXPERIENCED A PUMP VIBRATION, OR AT LEAST HAD NO PERCEPTION OF UNEXPECTED PUMP BEHAVIOR, NOR WERE THEY ANY COMPLAINTS IN THE MORNING ON THE SAME DAY, WHEN THE PATIENT WENT TO THE LAB FOR COAGULATION CONTROL. THE PATIENT WAS THEN TRANSPORTED TO INTENSIVE CARE, WHERE HE COLLAPSED. THE PATIENT WAS INTUBATED AFTER WHICH RESUSCITATION WAS PERFORMED. A DECISION WAS MADE TO EXCHANGE THE PUMP AS WELL AS THE INFLOW CANNULA AND OUTFLOW GRAFT. UPON EXPLANT, THE PARTS OF THE LVAD SYSTEM WERE VISUALLY INSPECTED BY THE HOSPITAL TEAM AND A THROMBUS FORMATION WAS OBSERVED IN THE PUMP HOUSING.

    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 88121

    Patients

    Seq Age Sex Outcome Treatment
    1 23 YR Required Intervention