BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 1935524 · Received November 8, 2010

    Report

    Report Number
    2953200-2010-02169
    Event Type
    Malfunction
    Date Received
    November 8, 2010
    Date of Event
    October 14, 2010
    Report Date
    October 15, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL, RESULTS/CONCLUSION: SEVERLY CALCIFIED AND MODERATE TORTUOSITY VESSEL.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS THAT THE AORTA WAS SEVERELY CALCIFIED AND MODERATE TORTUOSITY. IT WAS REPORTED THAT THE DEVICE COULD NOT BE ADVANCED TO THE INTENDED LANDING ZONE. THE DEVICE WAS REMOVED FROM THE PT WITH OUT ISSUE. THERE WAS A KINK IN THE STENT GRAFT DELIVERY SYSTEM. THE PHYSICIAN CHANGED THE GUIDE WIRE AND ANOTHER TALENT DEVICE WAS USED TO COMPLETE THE CAUSE. THE DELIVERY SYSTEM WAS DISCARDED BY THE USER FACILITY. 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 V00542244

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK