BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1963888 · Received December 22, 2010

    Report

    Report Number
    2953200-2010-02631
    Event Type
    Malfunction
    Date Received
    December 22, 2010
    Date of Event
    December 1, 2010
    Report Date
    December 1, 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
    KS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS AND CONCLUSION: MILD TORTUOUSITY AND SEVERE CALCIFICATION OF THE ILIAC ARTERIES.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A 6 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK WAS 25 MM IN DIAMETER AND IT WAS 45 MM IN LENGTH. THE ILIAC ARTERIES HAD MILD CALCIFICATION AND SEVERE TORTUOSITY. IT WAS REPORTED THAT THE PHYSICIAN WAS UNABLE TO ADVANCE THE DELIVERY CATHETER TO THE INTENDED LANDING ZONE, DUE TO THE SEVERE TORTUOSITY OF THE VESSEL. THE PHYSICIAN ATTEMPTED WITH A BUDDY WIRE BUT STILL WAS UNABLE TO ADVANCE THE DEVICE TO INTENDED LANDING ZONE. THE DEVICE WAS REMOVED FROM THE PT. THERE WERE SOME MARKS/FRAYING ON THE DELIVERY SYSTEM, AND THE PHYSICIAN ELECTED NOT TO USE THE DEVICE. A SHEATH WAS INSERTED FOLLOWED BY INSERTION OF ANOTHER ANEURX STENT GRAFT TO INTENDED LANDING ZONE WITHOUT ISSUE. THE CASE WAS SUCCESSFULLY COMPLETED. 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 - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00535288

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK