BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 518161 · Received March 26, 2004

    Report

    Report Number
    2953200-2004-01082
    Event Type
    Injury
    Date Received
    March 26, 2004
    Date of Event
    March 1, 2004
    Report Date
    March 1, 2004
    Manufacturer
    MEDTRONIC AVE PERIPHERAL DIVISION
    Product Code
    MIH
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A 28 MM DIAMETER X 16 MM DIAMETER X 13.5 CM LENGTH ANEURX BIFURCATED STENT GRAFT AND ITS COMPONENTS WERE IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN 2001. IT WAS REPORTED THAT THE PT'S VESSELS WERE MODERATELY TORTUOUS AND CALCIFIED. PRE-IMPLANT ANEURYSM SIZE IS UNK. THE PT DEVELOPED A PERSISTENT TYPE II ENDOLEAK, FROM THE LUMBAR ARTERIES LOCATED NEAR THE AORTIC BIFURCATION. THE ENDOLEAK COULD NOT BE SUCCESSFULLY TREATED IN SPITE OF EFFORTS TO EMBOLIZE THE ENDOLEAK MULTIPLE TIMES. DUE TO THE ENDOLEAK, THE PT'S ANEURYSM HAD EXPANDED TO 6.2 CM. TWO AND HALF MONTHS LATER THE PT WAS BROUGHT TO THE OPERATING ROOM FOR EXPLANT OF THE STENT GRAFT. THE PROCEDURE WAS REPORTED TO BE SUCCESSFUL AND THE PT LEFT THE OPERATING ROOM IN SATISFACTORY CONDITION. THERE WAS NO CLINICAL SEQUELAE REPORTED, AND THE PT IS REPORTED TO BE ALIVE. THE EXPLANTED STENT GRAFT WAS RETURNED TO MEDTRONIC VASCULAR IN MARCH 2004 AND ITS EVALUATION IS PENDING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) AAA STENT GRAFT MIH MEDTRONIC AVE PERIPHERAL DIVISION NA M01H751024

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention