BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT

    MDR report key: 1130870 · Received August 21, 2008

    Report

    Report Number
    2953200-2008-00720
    Event Type
    Injury
    Date Received
    August 21, 2008
    Date of Event
    July 24, 2008
    Report Date
    July 24, 2008
    Manufacturer
    MEDTRONIC VASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULTS: (MIGRATION, ENDOLEAK). (AORTIC NECK ANGULATION). CONCLUSION: (AORTIC NECK ANGULATION). SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNK. IT WAS REPORTED APPROX 56 MONTHS POST STENT GRAFT IMPLANT THE CT DEMONSTRATED THAT THE STENT GRAFT HAD MIGRATED APPROX 3 CM RESULTING IN A DISTAL TYPE I ENDOLEAK. IT WAS REPORTED THAT THE STENT GRAFT MIGRATION WAS DUE TO THE ANGULATION OF THE AORTIC NECK. THE PHYSICIAN ELECTED TO TREAT THE PT WITH ANOTHER MFR'S AORTIC CUFF AND PERFORMED A FEMORAL TO FEMORAL BYPASS. THE TYPE I ENDOLEAK WAS RESOLVED. THE PT WAS REPORTED TO BE FINE AND NO ADD'L CLINICAL SEQUELAE HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX STENT GRAFT (FLEXIBLE) WITH XPEDIENT MIH MEDTRONIC VASCULAR NA 12272

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention