BEUDAMED
    FDA Adverse Event Other Summary report: N

    MEDTRONICS ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 639658 · Received September 6, 2005

    Report

    Report Number
    2953200-2005-01291
    Event Type
    Other
    Date Received
    September 6, 2005
    Report Date
    September 6, 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 26 MM DIAMETER X 15 MM DIAMETER X 13.5 MM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED INTO A PT FOR THE ENDOVASCULAR TREATMENT IF AN ABDOMINAL AORTIC ANEURYSM. CURRENTLY IT IS UNK WHETHER OR NOT THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AS NO INFORMATION HAS BEEN PROVIDED REGARDING THIS EVENT. NO CONCLUSION CAN BE DRAWN AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONICS ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC VASCULAR NA M0077158

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Other