BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2062283 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00666
    Event Type
    Malfunction
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS AND CONCLUSION: SEVERELY CALCIFIED AND TORTUOUS ILIAC ARTERIES.

    Description of Event or Problem · 1

    AN ABDOMINAL STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A 7.5 CM ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT THE AORTIC NECK DIAMETER IS 21.6 MM IN DIAMETER AT THE RENAL ARTERY, 21 MM IN DIAMETER PROXIMALLY, 22.5 MM IN DIAMETER DISTALLY AND IT WAS 10.5 MM IN LENGTH. THERE WAS AN ALREADY OCCLUDED RCIA WITH A LUMEN OF 3.4 MM. THE LCIA IS 10.7 MM AND DISTALLY 11.4 MM. THE VESSELS WERE TORTUOUS AND HEAVILY CALCIFIED. THE ENDURANT BIFURCATED STENT GRAFT WAS SUCCESSFULLY PLACED. IT WAS REPORTED THAT THE ANEURX DELIVERY SYSTEM KINKED WHILE IT WAS BEING ADVANCED IN THE PT. THE DELIVERY CATHETER WAS REMOVED FROM THE PT WITHOUT ISSUE. THE PHYSICIAN TREATED THE PT WITH ANOTHER ANEURX DEVICE AND THE CASE WAS SUCCESSFULLY COMPLETED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00511896

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR