BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT

    MDR report key: 519043 · Received April 2, 2004

    Report

    Report Number
    2953200-2004-01094
    Event Type
    Injury
    Date Received
    April 2, 2004
    Date of Event
    March 2, 2004
    Report Date
    March 2, 2004
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIV
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 22 MM DIAMETER X 13 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2000. VESSEL MORPHOLOGY AND ANEURYSM SIZE IS UNKNOWN. IT WAS REPORTED THAT THE AORTIC NECK WAS AT A 90-DEGREE ANGLE. THE PT PRESENTED WITH A CONTAINED RUPTURE FROM A TYPE I ENDOLEAK. IT WAS REPORTED THAT THERE WAS ALSO A TYPE II ENDOLEAK. 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. THE PT IS REPORTED TO BE DOING WELL. THE EXPLANTED STENT GRAFT WAS RECEIVED BY MEDTRONIC VASCULAR IN 4/2004 AND ITS EVAL IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIV NA M9975816

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention