BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 663714 · Received January 12, 2006

    Report

    Report Number
    2953200-2006-00012
    Event Type
    Injury
    Date Received
    January 12, 2006
    Date of Event
    December 12, 2005
    Report Date
    December 14, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS REPORTED THAT THE PATIENT'S AORTIC NECK DILATED RESULTING IN DISTAL STENT GRAFT MIGRATION. THE PATIENT WAS SUCCESSFULLY TREATED WITH AN ANEURX CUFF IN ADDITION TO 2 TALENT AORTIC CUFFS UNDER IDE (G020050). NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M02M552337

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention