BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 4487519 · Received February 5, 2015

    Report

    Report Number
    3008011247-2015-00012
    Event Type
    Malfunction
    Date Received
    February 5, 2015
    Date of Event
    January 9, 2015
    Report Date
    January 9, 2015
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    BE
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ONLY THE DELIVERY CATHETER WAS RETURNED FOR EVALUATION; THE STENT GRAFT REMAINS IMPLANTED.

    Description of Event or Problem · 1

    AN OVATION PRIME ABDOMINAL STENT GRAFT WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. FOLLOWING ROUTINE DEPLOYMENT OF THE AORTIC BODY STENT GRAFT, THE POLYMER SYRINGE EMPTIED AND THE PATIENT EXPERIENCED TRANSIENT HYPOTENSION WHICH WAS TREATED PER THE INSTRUCTIONS FOR USE AND THE PATIENT WAS STABILIZED INTRAOPERATIVELY. THE CONTRALATERAL AND IPSILATERAL ILIAC LIMB STENT GRAFTS WERE DEPLOYED WITHOUT INCIDENT AND THE ANEURYSM WAS SUCCESSFULLY EXCLUDED. FOLLOWING THE IMPLANT PROCEDURE, THE PATIENT WAS TRANSFERRED TO ICU AND WAS REPORTED TO HAVE PARALYSIS DUE TO EITHER INTRAPROCEDURAL EMBOLISM OF THROMBUS OR SPINAL CORD ISCHEMIA SECONDARY TO OCCLUSION OF LUMBARS BY THE STENT GRAFT. THE PATIENT WILL CONTINUE TO BE MONITORED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    84708 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-D FS081114-58

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention