BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO

    MDR report key: 1963336 · Received January 14, 2011

    Report

    Report Number
    2953200-2011-00126
    Event Type
    Injury
    Date Received
    January 14, 2011
    Date of Event
    December 16, 2010
    Report Date
    December 16, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    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). EVAL RESULTS AND CONCLUSION: (ENDOLEAK), OTHER (CAUSE OF TYPE III ENDOLEAK UNK).

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 7 CM ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY FOR ACCESS VESSELS WAS REPORTED AS HAVING NO TORTUOSITY AND MODERATE CALCIFICATION, WITH AORTIC NECK ANGULATION OF 15-20 DEGREES. A TYPE III ENDOLEAK WAS SEEN IN THE LEFT ILIAC VESSEL AFTER IMPLANTATION OF THE BIFURCATED STENT AND LEFT CONTRALATERAL LIMB. THE PHYSICIAN RELINED THE CONTRALATERAL LIMB WITH AN ANEURX STENT GRAFT AND THE ISSUE WAS RESOLVED. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PT IS FINE. (MFR REPORT# 2953200-2011-00126, 2953200-2011-00127).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM WITH XCELERANT - HYDRO MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00447736

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention