BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ANEURX AAADVANTAGE STENT GRAFT SYSTEM

    MDR report key: 2013215 · Received March 8, 2011

    Report

    Report Number
    2953200-2011-00610
    Event Type
    Injury
    Date Received
    March 8, 2011
    Date of Event
    February 28, 2013
    Report Date
    March 1, 2013
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: MIGRATION, ENDOLEAK; DISEASE PROGRESSION RESULTING IN AORTIC NECK DILATATION. CONCLUSION: DISEAE PROGRESSION WITH DILATATION OF THE AORTIC NECK.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION WAS RECEIVED AS FOLLOWS: IT WAS REPORTED THAT A RECENT CT DEMONSTRATED A DISTAL TYPE I ENDOLEAK IN THE IPSILATERAL LIMB. THERE IS DISEASE PROGRESSION WITH ILIAC LIMB DILATATION. THE PHYSICIAN ELECTED TO IMPLANT A 16X24X93 ENDURANT ILIAC EXTENSION. THE DISTAL TYPE I ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 3.5 YEARS AGO. THE PT WAS ORIGINALLY IMPLANTED IN ANOTHER STATE THEREFORE THE ANEURYSM AND VESSEL MORPHOLOGY FROM THE TIME OF IMPLANT ARE UNK. IT IS UNK WHETHER THE PT RETURNED FOR FOLLOW-UP. IT WAS REPORTED THAT CURRENTLY THE PT HAS DISEASE PROGRESSION WITH AORTIC NECK DILATATION, THE AORTIC NECK IS 26 MM IN DIAMETER AT THE RENAL ARTERIES AND IT IS 2 CM LONG. A RECENT CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED 2 CM DISTALLY RESULTING IN A TYPE I ENDOLEAK. THE PHYSICIAN IMPLANTED A 32 MM TALENT AORTIC CUFF PROXIMALLY TO THE ANEURX BIFURCATED STENT GRAFT; HOWEVER, THE ENDOLEAK DID NOT RESOLVE (REF MFR# 2953200-2011-00611). A PALMAZ STENT WAS IMPLANTED WITHIN THE TALENT CUFF AND THE ENDOLEAK WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ANEURX AAADVANTAGE STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00025722

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Required Intervention