BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 522116 · Received April 23, 2004

    Report

    Report Number
    2953200-2004-01113
    Event Type
    Injury
    Date Received
    April 23, 2004
    Date of Event
    March 18, 2004
    Report Date
    March 30, 2004
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 20MM DIAMETER X 12MM DIAMETER X 13.5CM LENGTH ANEURYSM BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 1999. VESSEL MORPHOLOGY AND ANEURYSM SIZE ARE UNKNOWN. IT WAS REPORTED IN 2004 THE PT WAS BROUGHT TO THE OPERATING ROOM FOR REPAIR OF A TYPE I ENDOLEAK. AN ANEURX ILIAC EXTENSION CUFF AND A PALMAZ STENT WERE PLACED, HOWEVER THE ENDOLEAK WAS NOT RESOLVED. IN 2004 THE PT WAS BROUGHT TO THE OPERATING ROOM FOR EXPLANT OF THE STENT GRAFT. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL AND THE PT LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. THERE WAS NO CLINICAL SEQUELAE REPORTED, AND THE PT IS REPORTED TO BE DOING WELL. THE EXPLANTED STENT GRAFT WAS RETURNED TO MEDTRONIC VASCULAR IN 2004 AND ITS EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M9915421

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention