BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO

    MDR report key: 1202446 · Received October 8, 2008

    Report

    Report Number
    2953200-2008-00909
    Event Type
    Malfunction
    Date Received
    October 8, 2008
    Date of Event
    September 8, 2008
    Report Date
    September 8, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    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: BACK END -CPC INSERT.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT DEVICE WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY WERE NOT REPORTED. IT WAS REPORTED PRIOR TO DEPLOYMENT OF THE STENT GRAFT THE BACK END CPC INSERT WAS DETACHED FROM THE DELIVERY CATHETER; HOWEVER, THE PHYSICIAN WAS ELECTED USE OF THE DEVICE WITHOUT THE BACK END CPC INSERT. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED AND THE PT IS FINE. THE ANALYSIS FOR THE RETURNED DEVICE HAS BEEN COMPLETED. THE COMPLAINT WAS CONFIRMED AS REPORTED. THE CPC INSERT WAS FOUND TO BE FRACTURED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM-HYDRO MIH MEDTRONIC VASCULAR NA V00081046

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK