BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO

    MDR report key: 1241904 · Received November 19, 2008

    Report

    Report Number
    2953200-2008-01083
    Event Type
    Malfunction
    Date Received
    November 19, 2008
    Date of Event
    October 30, 2008
    Report Date
    October 30, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS, CONCLUSION: LACK OF INFO (DEVICE NOT RETURNED FOR EVAL).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSELS WERE NOT HEAVILY CALCIFIED AND NOT TORTUOUS. IT WAS REPORTED THAT THERE WAS SOME DIFFICULTY RETRACTING THE RUNNERS AFTER THE STENT GRAFT WAS SUCCESSFULLY DEPLOYED. THE RUNNERS AND NOSE CONE WERE SUCCESSFULLY RETRACTED INTO THE GRAFT BY ROTATION OF THE SCREW GEAR. THE DELIVERY SYSTEM WAS NOT RETURNED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM - HYDRO MIH MEDTRONIC CARDIOVASCULAR NA V00155620

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR