BEUDAMED
    FDA Adverse Event Death Summary report: N

    OVATION IX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 6276841 · Received January 25, 2017

    Report

    Report Number
    3008011247-2017-00006
    Event Type
    Death
    Date Received
    January 25, 2017
    Date of Event
    December 29, 2016
    Report Date
    December 30, 2016
    Manufacturer
    TRIVASCULAR, INC.
    Product Code
    MIH
    UDI-DI
    M701TVAB2680J1
    PMA / PMN Number
    P120006
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN OVATION IX ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED TO TREAT AN ABDOMINAL AORTIC ANEURYSM. ONE MONTH POST-OPERATIVE, THE PATIENT PRESENTED WITH ABDOMINAL PAIN, CHEST PAIN, BACK PAIN, AND VOMITING. THE PHYSICIAN SUSPECTED A POTENTIAL GRAFT INFECTION AND ELECTED TO EXPLANT THE DEVICE. THE PATIENT EXPIRED DURING THE EXPLANT PROCEDURE. A REVIEW OF THE CASE CT IMAGING SHOWED INDICATIONS THAT THE INFECTION IS RELATED TO A MYCOTIC THORACOABDOMINAL ANEURYSM. THERE WERE NO FINDINGS DURING THE THAT INDICATE THAT THE REPORTED DEVICE HAD A CONNECTION WITH THE PATIENT'S REPORTED INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59885 OVATION IX ABDOMINAL STENT GRAFT SYSTEM ENDOVASCULAR GRAFT, ABDOMINAL AORTIC ANEURYSM MIH TRIVASCULAR, INC. TV-AB2680-J FS021816-36 M701TVAB2680J1

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Death| R SURGICAL CONVERSION/EXPLANT