BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE)

    MDR report key: 1953496 · Received January 5, 2011

    Report

    Report Number
    2953200-2011-00006
    Event Type
    Injury
    Date Received
    January 5, 2011
    Date of Event
    December 7, 2010
    Report Date
    December 7, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P990020
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION, RESULTS: (MIGRATION, ENDOLEAK). RESULTS/CONCLUSIONS: (DISEASE PROGRESSION AND AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    AN ANEURX STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 8 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT AND CURRENTLY ARE UNKNOWN. THE ILIAC VESSELS HAVE SEVERE TORTUOSITY AND ARE SMALL IN DIAMETER. CURRENTLY THERE IS DISEASE PROGRESSION WITH AORTIC NECK DILATION. THE PATIENT WAS LOST TO FOLLOW-UP; THE PATIENT WAS LAST SEEN ONE YEAR AFTER INITIAL IMPLANT. ON AN UNKNOWN DATE THE CONTRALATERAL ILIAC STENT GRAFT LIMB WAS OCCLUDED AND A FEMORAL TO FEMORAL BYPASS WAS PERFORMED. A CT DEMONSTRATED THAT THE STENT GRAFT HAS MIGRATED WITH A TYPE I ENDOLEAK PRESENT (MFR 2953200-2011-00007). THE PHYSICIAN PLANS TO TREAT THE PATIENT THIS MONTH WITH A TALENT CONVERTER DEVICE. NO ADDITIONAL CLINICAL SEQUELAE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDTRONIC ANEURX BIFURCATED STENT GRAFT (FLEXIBLE) MIH MEDTRONIC CARDIOVASCULAR NA M02L551096

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention