BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 1030252 · Received April 17, 2008

    Report

    Report Number
    2953200-2008-00225
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    March 8, 2008
    Report Date
    March 20, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THERE IS NO CALCIFICATION IN THE VESSELS. THE PT'S VESSELS HAVE SEVERE DISEASE PROGRESSION WITH THE AORTIC NECK DILATATION AND THE MILD AORTIC NECK ANGULATION. THE VESSELS DIAMETERS HAVE CHANGED FROM 23-28 MM IN DIAMETER TO 30 MM IN DIAMETERS. THE ANEURYSM SIZE AT THE TIME OF THE EVENT IS 8.5 CM. IT WAS REPORTED APPROX 53 MOS POST STENT GRAFT IMPLANTATION THE CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED RESULTING IN A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THAT THE STENT GRAFT MIGRATION WAS DUE TO SEVERE DISEASE PROGRESSION AND AORTIC NECK ANGULATION. THE PHYSICIAN ELECTED TO TREAT THE PT WITH ONE AORTIC CUFF FROM ANOTHER MFR. THE TYPE I ENDOLEAK WAS RESOLVED. THE PT WAS REPORTED TO BE FINE AND NO ADD'L CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC CARDIOVASCULAR NA M03J551511

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention