BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 774309 · Received October 24, 2006

    Report

    Report Number
    2953200-2006-00282
    Event Type
    Injury
    Date Received
    October 24, 2006
    Date of Event
    September 25, 2006
    Report Date
    September 25, 2006
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    p990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 24MM DIAMETER X 14 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 AT TIME OF IMPLANT ARE UNK. THE AORTIC NECK LENGTH APPEARS TO BE AT APPROX 4.5- 5.5 CM IN LENGTH. IT WAS REPORTED THAT APPROX 45 MONTHS POST STENT GRAFT IMPLANT, THE FOLLOW-UP CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED APPROX 4.5 TO 5.5 CM RESULTING IN A TYPE I ENDOLEAK. IT WAS REPORTED THAT THE STENT GRAFT MIGRATED INTO THE ANEURYSM SAC. THE PHYSICIAN HAS REQUESTED A TALENT AORTIC CUFF UNDER IDE (G020050), DUE TO THE CO-MORBIDITIES OF THE PT WHO IS NOT A GOOD CANDIDATE FOR AN OPEN SURGICAL REPAIR. IT WAS REPORTED THAT THE EXPANSION OF THE AORTIC NECK DUE TO DISEASE PROGRESSION CONTRIBUTED TO THE MIGRATION OF THE STENT GRAFT. THE PHYSICIAN ELECTED TO REPAIR THE STENT GRAFT WITH THE IMPLANT OF TWO AORTIC CUFFS. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MIH MEDTRONIC VASCULAR NA M03B550278

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Required Intervention