BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFTY SYSTEM - HYDRO

    MDR report key: 1959891 · Received January 6, 2011

    Report

    Report Number
    2953200-2011-00033
    Event Type
    Malfunction
    Date Received
    January 6, 2011
    Date of Event
    December 10, 2010
    Report Date
    December 10, 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
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4): RESULTS AND CONCLUSION: (MODERATELY CALCIFIED AND TORTUOUS VESSELS).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS INSERTED INTO A PT FOR THE TREATMENT OF A 5.1 CM ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE MODERATELY CALCIFIED AND MODERATELY TORTUOUS. IT WAS REPORTED THAT THE DEVICE COULD NOT BE ADVANCED TO THE INTENDED LANDING ZONE. THE DEVICE WAS REMOVED FROM THE PT AND IT WAS FOUND KINKED. THE PHYSICIAN CHANGED TO ANOTHER DEVICE, CHANGED THE WIRES FROM AMPLATZ TO LUNDERQUIST AND WAS ABLE TO ADVANCE AND SUCCESSFULLY IMPLANT THE STENT GRAFT SYSTEM. THE DEVICE WAS DISCARDED. 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 GRAFTY SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00550915

    Patients

    Seq Age Sex Outcome Treatment
    1 71 YR