BEUDAMED
    FDA Adverse Event Injury Summary report: N

    OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3954984 · Received July 24, 2014

    Report

    Report Number
    3008011247-2014-00053
    Event Type
    Injury
    Date Received
    July 24, 2014
    Date of Event
    June 24, 2014
    Report Date
    June 24, 2014
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GM
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    REMAINS IMPLANTED.

    Description of Event or Problem · 1

    THE PATIENT UNDERWENT ENDOVASCULAR REPAIR OF AAA USING THE OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ON (B)(6) 2014. AFTER DEPLOYMENT OF THE AORTIC BODY GRAFT, THE PHYSICIAN ENCOUNTERED DIFFICULTIES CANNULATING THE CONTRALATERAL GATE, AND THE PATIENT WAS CONVERTED TO AN AORTO-UNI ILIAC (AUI) WITH A FEM-FEM BYPASS TO MAINTAIN FLOW TO THE LIMBS. THE CAUSE OF THE CANNULATION DIFFICULTIES IS INDETERMINATE BUT MAY BE THE RESULT OF COMPRESSION OF THE CONTRALATERAL LEG OF THE AORTIC BODY GRAFT AND/OR CALCIUM ON THE POSTERIOR WALL OF THE AORTA; HOWEVER, THIS COULD NOT BE DEFINITIVELY CONFIRMED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    434821 OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB3480-D FS031814-05

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Required Intervention AUI DEVICE