BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 621345 · Received July 15, 2005

    Report

    Report Number
    2953200-2005-01176
    Event Type
    Injury
    Date Received
    July 15, 2005
    Date of Event
    March 19, 2003
    Report Date
    March 25, 2003
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 25 MM DIAMETER X 15 MM DIAMETER X 13.5 CM ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL TORTUOSITY AND CALCIFICATION ARE UNKNOWN. THE ANEURYSM SAC HAS INCREASED FROM 5 CM TO 5.3 CM WITHIN 7 MONTHS AND A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. THE AORTIC NECK DIAMETER HAS INCREASED SINCE THE TIME OF IMPLANT, RESULTING IN THE NEED OF A 32 MM AORTIC CUFF. IT WAS REPORTED THAT 20 MONTHS POST IMPLANT THE CT DEMONSTRATED THE PRESENCE OF A TYPE I ENDOLEAK RESULTING IN THE EXPANSION OF THE AORTIC ANEURYSM. THE PT IS NOT A SURGICAL CANDIDATE DUE TO PT'S AGE, HEALTH STATUS AND CO-MORBIDITES. THE PHYSICIAN ELECTED TO IMPLANT AN ANEURX AORTIC CUFF AND A TALENT AORTIC CUFF WITH A SUCCESSFUL OUTCOME.

    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 M01C750173

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention