BEUDAMED
    FDA Adverse Event Death Summary report: N

    HEARTMATE XVE LVAS

    MDR report key: 1327505 · Received February 26, 2009

    Report

    Report Number
    2916596-2009-00046
    Event Type
    Death
    Date Received
    February 26, 2009
    Date of Event
    January 30, 2009
    Report Date
    January 31, 2009
    Manufacturer
    THORATEC CORP.
    Product Code
    DSQ
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NJ, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE WAS NOT EXPLANTED FROM THE PATIENT. 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 VENTED ELECTRIC LEFT VENTRICULAR ASSIST DEVICE (LVAD). THE VAD COORDINATOR REPORTED THAT PRE-OPERATION, THE PATIENT HAD AN ENGORGEMENT OF THE LIVER WHICH RESULTED IN AUTO-ANTI-COAGULATION THROUGHOUT THE SURGICAL PROCEDURE. THE LVAD WAS SUCCESSFULLY IMPLANTED; HOWEVER, AFTER INITIATION OF THE PUMP, IT WAS NOTED THAT THE OUTFLOW GRAFT OOZED SIGNIFICANTLY. THE PATIENT WAS TRANSFERRED TO THE ICU WITH CONTINUED CHEST TUBE DRAINAGE AND APPROX. TWO HOURS LATER WAS RETURNED TO THE OR FOR IMPLANTATION OF ABIOMED BVS-5000 FOR RIGHT SIDED SUPPORT. THE PATIENT CONTINUED TO BLEED THROUGHOUT THE NIGHT AND WAS REPORTED TO HAVE EXPIRED THE NEXT MORNING. THE HOSPITAL DID NOT REPORT THE CAUSE OF DEATH TO THE MANUFACTURER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 HEARTMATE XVE LVAS LEFT VENTRICULAR ASSIST DEVICE DSQ THORATEC CORP. 1270 63897

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Death| R