BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 7164417 · Received January 4, 2018

    Report

    Report Number
    7164417
    Event Type
    Malfunction
    Date Received
    January 4, 2018
    Date of Event
    December 5, 2017
    Report Date
    December 20, 2017
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    NC, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    A MID-80S FEMALE WAS UNDERGOING AN ENDOVASCULAR ANEURYSM REPAIR (EVAR) PROCEDURE. DURING THE PROCEDURE, THERE WAS DIFFICULTY DELIVERING THE EQUIPMENT DUE TO THE TORTUOSITY OF THE ABDOMINAL AORTA. THE NOSE CONE OF THE DELIVERY SYSTEM CAUGHT ON A STENT STRUT AND BROKE. THE DEVICE WAS SECURED TO THE AORTIC WALL WITH A PALMAZ XL STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    7686 OVATION IX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH TRIVASCULAR, INC. AORTIC BODY FS062317-61

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR THE PATIENT WAS UNDERGOING AN EVAR PROCEDURE. THE