BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1053603 · Received May 23, 2008

    Report

    Report Number
    2953200-2008-00363
    Event Type
    Injury
    Date Received
    May 23, 2008
    Date of Event
    April 23, 2008
    Report Date
    April 28, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN 8.0 CM ABDOMINAL AORTIC ANEURYSM. THERE IS NO CALCIFICATION IN THE VESSELS. THE PATIENT'S VESSELS HAVE SEVERE DISEASE PROGRESSION WITH THE AORTIC NECK DILATATION AND 90 PERCENT AORTIC NECK ANGULATION. THE ANEURYSM SIZE AT THE TIME OF THE EVENT IS 7.0 CM, HOWEVER, ONE YEAR PRIOR THE ANEURYSM WAS 6.0 CM. IT WAS REPORTED THAT THE PATIENT HAD BEEN TREATED IN 2005 WITH AN AORTIC CUFF DUE TO THE MIGRATION OF THE STENT GRAFT. IT WAS REPORTED APPROXIMATELY 75 MONTHS POST STENT GRAFT IMPLANTATION, THE CT DEMONSTRATED THAT THE BIFURCATED STENT GRAFT SEPARATED FROM THE AORTIC CUFF. THE STENT GRAFT MIGRATED INTO THE ANEURYSM SAC. IT WAS REPORTED THAT THE STENT GRAFT MIGRATION WAS DUE TO SEVERE DISEASE PROGRESSION AND SEVERE AORTIC NECK ANGULATION. THE PHYSICIAN ELECTED TO TREAT THE PATIENT WITH THREE AORTIC CUFFS AND TWO TALENT AORTIC CUFFS. 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 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M01L551110

    Patients

    Seq Age Sex Outcome Treatment
    1 72 YR Required Intervention