BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HEARTMATE II LVAD

    MDR report key: 1880347 · Received October 20, 2010

    Report

    Report Number
    2916596-2010-00265
    Event Type
    Injury
    Date Received
    October 20, 2010
    Date of Event
    September 24, 2010
    Report Date
    September 24, 2010
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE PATIENT REMAINS ON GOING WITH THE IMPLANTED DEVICE AND NO FURTHER ISSUES HAVE BEEN REPORTED. NO FURTHER INFO IS AVAILABLE AT THIS TIME. A SUPPLEMENTAL REPORT WILL BE SUBMITTED WHEN THE MFR'S INVESTIGATION IS COMPLETED.

    Description of Event or Problem · 1

    DURING THE IMPLANTATION OF A LEFT VENTRICULAR ASSIST DEVICE (LVAD), IT WAS REPORTED BY THE VAD COORDINATOR THAT AFTER INFLOW GRAFT HAD BEEN PRECLOTTED WITH TISSEEL AND THE LVAD PUMP WAS PRIMED WITH SALINE AND INSERTED INTO THE PT, IT WAS THEN NOTED THAT THE INFLOW GRAFT APPEARED TO BE LEAKING AND AIR ENTRAINED IN THE LEFT VENTRICULAR. THE SURGEON PLACED BONE WAX AROUND THE LEAKING SPOT AND THE AIR ENTRAINMENT STOPPED, DE-AIRING WAS COMPLETED AND THERE WERE NO FURTHER ISSUES.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR