BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 3002983 · Received March 13, 2013

    Report

    Report Number
    2953200-2013-00456
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    January 22, 2013
    Report Date
    February 16, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION RESULTS: PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DILATATION OF THE ILIAC ARTERY). EVALUATION CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DILATATION OF THE ILIAC ARTERY). (B)(4).

    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. ANEURYSM MORPHOLOGY FROM THE TIME OF IMPLANT IS UNKNOWN. IT WAS REPORTED THAT FOLLOW-UP IMAGING REVEALED STENT GRAFT MIGRATION WITH A PROXIMAL TYPE I ENDOLEAK DUE TO AORTIC NECK DILATATION AND ILIAC ARTERY DILATATION OF THE CONTRALATERAL LIMB. THE IMAGING SHOWED THE AORTIC NECK DIAMETER MEASURED 19-22MM WITH AN INFRA-RENAL NECK ANGULATION OF 77.7 DEGREES. APPROXIMATELY TWO WEEKS AGO THE EXISTING STENT GRAFT WAS RE-LINED WITH AN ENDURANT BIFURCATED STENT GRAFT 2516124 AND AN ILIAC LIMB 161693 EXTENDING THE STENT GRAFT IN THE AORTIC NECK, BUT NOT EXTENDING THE CONTRALATERAL LIMB. THE MIGRATION AND PROXIMAL TYPE I ENDOLEAK WERE SUCCESSFULLY RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    106098 ANEURX ABDOMINAL STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC CARDIOVASCULAR

    Patients

    Seq Age Sex Outcome Treatment
    1 00078 YR Required Intervention