BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1992863 · Received February 4, 2011

    Report

    Report Number
    2953200-2011-00273
    Event Type
    Malfunction
    Date Received
    February 4, 2011
    Date of Event
    January 6, 2011
    Report Date
    January 6, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (SEVERE TORTUOSITY OF THE ILIAC ARTERIES). CONCLUSION: (SEVERE TORTUOSITY OF THE ILIAC ARTERIES).

    Description of Event or Problem · 1

    AN ENDURANT STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR EMERGENT TREATMENT OF A 13 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS SEVERE ANGULATION OF THE PROXIMAL NECK ANATOMY AND SEVERE TORTUOSITY OF THE ILIAC ARTERIES. PROXIMAL NECK DIAMETER MEASURED 23-25 FOR 2CM. RICA WAS 19-21-21; LCIA WAS 28-26-25-25. IT WAS REPORTED THAT THE ENDURANT BIFURCATED STENT GRAFT WAS DEPLOYED AS WERE THE ILIAC LIMBS AND EXTENSIONS WITHOUT INCIDENT. THERE WAS ROOM IN THE LCIA ABOVE THE HYPOGASTRIC ARTERY FOR ONE MORE EXTENSION. THE PHYSICIAN SELECTED AN ANEURX 28 AORTIC CUFF, HOWEVER, THE DELIVERY CATHETER WOULD NOT ADVANCE TO THE INTENDED LANDING ZONE. THE DEVICE WAS REMOVED FROM THE PT AND IT WAS NOTED THERE WAS A KINK IN THE DELIVERY CATHETER. THE DEVICE WAS NOT USED AND WAS DISCARDED. THERE WERE NO ENDOLEAKS, SO IT WAS DECIDED TO FINISH THE CASE WITHOUT EXTENDING DOWN TO THE HYPOGASTRIC ARTERY. 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 CARDIOVASCULAR GALWAY NA V00471851

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR