BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 621073 · Received June 13, 2005

    Report

    Report Number
    2953200-2005-01221
    Event Type
    Injury
    Date Received
    June 13, 2005
    Date of Event
    June 13, 2005
    Report Date
    June 13, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, 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 WAS IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. SIXTY MONTHS POST STENT GRAFT IMPLANTATION A REQUEST FOR A TALENT AORTIC CUFF UNDER IDE (G020050) WAS REQUESTED. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED THAT 60 MONTHS POST STENT GRAFT IMPLANT THE CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED. IT WAS REPORTED THAT THE ANEURYSM HAD ENLARGED TO 8.3 CM. THE AORTIC NECK HAD SIGNIFICANTLY ENLARGED TO 4 CM DUE TO DISEASE PROGRESSION. THE PHYSICIAN REQUESTED A TALENT AORTIC CUFF HOWEVER, THERE WILL BE NO FURTHER TREATMENT DUE TO THE INCREASED SIZE OF THE AORTIC NECK.

    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 M0078739

    Patients

    Seq Age Sex Outcome Treatment
    1 87 YR Life Threatening