BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT SYSTEM

    MDR report key: 975388 · Received January 8, 2008

    Report

    Report Number
    2953200-2008-00006
    Event Type
    Injury
    Date Received
    January 8, 2008
    Report Date
    December 10, 2007
    Manufacturer
    MEDTRONIC CARIDO VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    VARIOUS ANEURX STENT GRAFT DELIVERY SYSTEM WERE IMPLANTED INTO VARIOUS PATIENT'S FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM IN PATIENT'S THAT HAD CHALLENGING AORTIC NECK ANATOMY. THE PHYSICIAN REPORTED THERE WERE STENT GRAFT MIGRATIONS AND SOME INCIDENTS OF ENDOLEAKS IN THE FOLLOWING JOURNAL ARTICLE: J VASC SURG 2006;44;932-7 EFFECT OF CHALLENGING NECK ANATOMY ON MID-TERM MIGRATION RATES IN ANEURX ENDOGRAFTS; FULTON ET AL 932-937. WHILE IT IS POSSIBLE THAT MEDTRONIC HAS ALREADY CAPTURED THE MIGRATION IN PREVIOUS MDR REPORTING, THIS INFORMATION IS BEING REPORTED AT THIS TIME, AS THERE IS NO FURTHER INFORMATION PROVIDED IN THE JOURNAL ARTICLE TO DETERMINE WHERE THE EVENT TOOK PLACE, IMPLANTING PHYSICIAN OR OTHER SPECIFIC PATIENT INFORMATION. NO FURTHER INVESTIGATION COULD BE CONDUCTED ON THESE COMPLAINTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT SYSTEM MIH MEDTRONIC CARIDO VASCULAR NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK YR Required Intervention