BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM

    MDR report key: 1071338 · Received July 8, 2008

    Report

    Report Number
    2953200-2008-00516
    Event Type
    Injury
    Date Received
    July 8, 2008
    Date of Event
    June 9, 2008
    Report Date
    June 9, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SECONDARY INTERVENTION REQUIRED).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF A 10 CM ABDOMINAL AORTIC ANEURYSM. THE AORTIC NECK ANGULATION IS 25 DEGREES. THE PATIENT'S VESSELS HAVE DISEASE PROGRESSION WITH THE AORTIC NECK DILATION. THE VESSELS DIAMETERS AT THE TIME OF IMPLANT ARE UNKNOWN. IT WAS REPORTED APPROXIMATELY 33 MONTHS POST STENT GRAFT IMPLANTATION, THE CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED RESULTING IN A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THAT THE STENT GRAFT MIGRATION WAS DUE TO DISEASE PROGRESSION RESULTING IN AORTIC NECK DILATATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH AN ANEURX AORTIC CUFF. THE TYPE I ENDOLEAK WAS RESOLVED. THE PATIENT WAS REPORTED TO BE FINE AND NO ADDITIONAL CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT WITH XCELERANT DELIVERY SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA 668109

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention