BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 856331 · Received May 29, 2007

    Report

    Report Number
    2953200-2007-00213
    Event Type
    Malfunction
    Date Received
    May 29, 2007
    Date of Event
    April 30, 2007
    Report Date
    April 30, 2007
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION SUMMARY: THE DELIVERY SYSTEM WAS RETURNED TO MEDTRONIC AND THE INITIAL ANALYSIS HAS BEEN COMPLETED. THE BULBED PORTION OF THE PEEK TUBE WAS BROKEN INSIDE OF THE TIP OF THE DELIVERY SYSTEM. THE ROOT CAUSE OF THE DEVICE FAILURE IS UNDETERMINED AT THIS TIME. THE INVESTIGATION IS ONGOING.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED INTO A PATIENT FOR ENDOVASCULAR TREATMENT OF ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNKNOWN. VESSEL MORPHOLOGY WAS REPORTED TO BE NON-CALCIFIED AND NON-TORTUOUS. IT WAS REPORTED THAT THE PHYSICIAN SUCCESSFULLY IMPLANTED THE AORTIC CUFF. UPON REMOVAL OF THE STENT DELIVERY SYSTEM, THE TIP OF THE CATHETER DETACHED FROM THE DELIVERY SYSTEM, BUT REMAINED WITHIN THE 22 FR INTRODUCER SHEATH. THE TIP OF THE CATHETER AND THE INTRODUCER SHEATH WERE REMOVED FROM THE PATIENT AS ONE UNIT. NO SEQUELAE WERE REPORTED AND THE PATIENT IS REPORTED TO BE FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC VASCULAR NA 10000226

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR