BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    OVATION IX ILIAC STENT GRAFT

    MDR report key: 11790702 · Received May 7, 2021

    Report

    Report Number
    11790702
    Event Type
    Malfunction
    Date Received
    May 7, 2021
    Date of Event
    April 16, 2021
    Report Date
    April 28, 2021
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    OH
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    IT IS DIFFICULT FOR HEALTHCARE PROVIDERS TO KNOW/NOTICE FROM THE STENT GRAFT PACKAGING, OF THE TRIVASCULAR® OVATION PRIME® ABDOMINAL STENT GRAFT SYSTEM WITH THE OVATION IX ILIAC STENT GRAFT, THAT IT IS A TAPERED (TS) STENT. THE STENT WAS PLACED DURING AN URGENT SITUATION. THE DESCRIPTION AT THE TOP OF THE PACKAGE IS VERY SIMILAR TO A NONTAPERED (NTS) STENT. THE PACKAGE ON THE LEFT (CATALOG # TV-EX282845-J) IS A NTS STENT AND THE RIGHT (CATALOG # TV-IL1428100-J) IS A TS STENT. WHEN REVIEWING THE SIZE, IT WAS EASILY MISSED, THE PICTURE ALSO DOES NOT NOTE A TAPER IN THE STENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    689170 OVATION IX ILIAC STENT GRAFT SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH TRIVASCULAR, INC. ILIAC EXTENSION

    Patients

    Seq Age Sex Outcome Treatment
    1 23725 DA