BEUDAMED
    FDA Adverse Event Other Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 573992 · Received February 18, 2005

    Report

    Report Number
    2953200-2005-01037
    Event Type
    Other
    Date Received
    February 18, 2005
    Report Date
    January 20, 2005
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    A 24 MM DIAMETER X 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT SYSTEM AND ITS COMPONENTS WERE IMPLANTED INTO A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. IT WAS CLAIMED THAT THE STENT GRAFT WAS DEFECTIVE. COMPANY HAS BEEN UNABLE TO OBTAIN ANY FURTHER INFORMATION. THE DEVICE WAS NOT RETURNED FOR ANALYSIS.

    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 MO3B552200

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Other