BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2032453 · Received March 25, 2011

    Report

    Report Number
    2953200-2011-00715
    Event Type
    Injury
    Date Received
    March 25, 2011
    Date of Event
    February 25, 2011
    Report Date
    February 25, 2011
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (STENT GRAFT MIGRATION, ENDOLEAK). (SHORT DISTAL LANDING ZONE AT IMPLANT). CONCLUSION: (SHORT DISTAL LANDING ZONE AT IMPLANT).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN 8.7CM ABDOMINAL AORTIC ANEURYSM APPROX 32 MONTHS AGO. VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WAS NOT REPORTED. AT THE TIME OF INITIAL IMPLANT, THE BIFURCATED STENT GRAFT IPSILATERAL LIMB WAS ONLY EXTENDED INTO THE ILIAC LIMB 1.5CM. IT WAS REPORTED THAT THE PT CAME IN FOR A ROUTINE F/U AND THE BIFURCATED STENT GRAFT IPSILATERAL LIMB HAD PULLED OUT OF THE ILIAC ARTERY AND RESULTED IN A DISTAL TYPE 1 ENDOLEAK. THE ANEURYSM WAS 8.2 CM TWO YEARS AGO AND CURRENTLY IS 9.2CM IN DIAMETER. THE PHYSICIAN ELECTED TO EXTEND THE STENT GRAFTS DOWN TO THE HYPOGASTRIC ARTERY WITH AN ILIAC LIMB AND THE ENDOLEAK WAS RESOLVED. NO ADD'L CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00101765

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention