BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONICS ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 627617 · Received August 5, 2005

    Report

    Report Number
    2953200-2005-01248
    Event Type
    Injury
    Date Received
    August 5, 2005
    Date of Event
    August 5, 2003
    Report Date
    August 5, 2003
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER Z 16.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT DELIVERY SYSTEM AND ITS COMPONENTS WERE IMPLANTED INTO PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMIANAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY ARE UNKNOWN. EIGHT MONTHS POST GRAFT IMPLANT THE PATIENT DEVELOPED ANEURYSM ENLARGEMENT DUE TO A PROXIMAL TYPE I. IT WAS REPORTED THAT THE PATIENT HAD A CONTAINED RUPTURE. THE PHYSICIAN THEN IMPLANTED TWO TALENT AORTIC CUFFS COVERED UNDER A TALENT AORTIC CUFF UNDER IDE (G020050). THE AORTIC CUFF COVERED THE LEFT RENAL ARTERY AND PARTIALLY COVERED THE RIGHT RENAL ORIFICE. A 6MM BALLOON WAS USED TO PUSH THE STENT GRAFT SLIGHTLY TO ALLOW FOR FILLING OF THE RIGHT RENAL ARTERY WHILE THE LEFT RENAL ARTERY REMAINED OCCLUDED.

    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 M02L552848

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention