BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE

    MDR report key: 3111286 · Received May 9, 2013

    Report

    Report Number
    2916596-2013-00501
    Event Type
    Injury
    Date Received
    May 9, 2013
    Date of Event
    April 11, 2013
    Report Date
    April 11, 2013
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE LVAD 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. THE VAD COORDINATOR REPORTED THAT THE PATIENT WAS TRANSFERRED TO THE ICU WITH NO SIGNS OR SYMPTOMS OF BLEEDING, THE CHEST WAS CLOSED, AND PUMP SPEED WAS OPTIMIZED. HOWEVER, HE BECAME HYPOTENSIVE DURING THE NIGHT WITH AN ELEVATED CENTRAL VENOUS PRESSURE AND SUSPECTED RIGHT VENTRICULAR FAILURE. HE WAS TAKEN TO THE CATH LAB ON (B)(6) 2013 IN CARDIOGENIC SHOCK. THE PATIENT WAS TRANSITIONED TO FULL CARDIOPULMONARY BYPASS SUPPORT. THE INTERNAL COMPONENTS OF THE PUMP WERE INSPECTED, AND THE PUMP WAS FOUND TO BE "FULL OF CLOTS." THE PUMP AND INFLOW CONDUIT WERE REPLACED. THE OUTFLOW GRAFT WAS INSPECTED, BUT NO EVIDENCE OF CLOT WAS VISUALIZED, SO IT REMAINED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    202713 HEARTMATE II LEFT VENTRICULAR ASSIST DEVICE LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 104911 117870

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other