BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 652580 · Received December 14, 2005

    Report

    Report Number
    2953200-2005-01420
    Event Type
    Injury
    Date Received
    December 14, 2005
    Date of Event
    November 9, 2005
    Report Date
    November 14, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 26 MM DIAMETER X 15 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNK. THE PT HAS A HISTORY OF CORONARY ARTERY DISEASE, RENAL INSUFFICIENCY AND AV STENOSIS. RECENTLY IT WAS REPORTED THAT THE STENT GRAFT HAD MIGRATED AND IS CURRENTLY 3 CM BELOW THE LEVEL OF THE RIGHT RENAL ARTERY WHERE PREVIOUSLY IT HAD ONLY BEEN 1.5 CM AND THE ANEURYSM HAD ENLARGED FROM 4.4 CM TO 5.2 CM. THE DR REQUESTED A TALENT AORTIC CUFF UNDER IDE (G020050) FOR REPAIR OF THE MIGRATION. THE TALENT AORTIC CUFF WAS IMPLANTED 6 DAYS AGO AND SUCCESSFULLY RESOLVED THE MIGRATION WITH NO ENDOLEAKS PRESENT. NO ADDITIONAL INFO WAS RECEIVED AND IT WAS REPORTED THAT THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M01E750079

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention
    2