BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1892660 · Received November 3, 2010

    Report

    Report Number
    2953200-2010-02140
    Event Type
    Injury
    Date Received
    November 3, 2010
    Date of Event
    October 8, 2010
    Report Date
    October 8, 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
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS - ENDOLEAK; RESULTS/CONCLUSIONS: AORTIC NECK ANGULATION WITH PROXIMAL CALCIFICATION.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK WAS 1 CM IN LENGTH, 23 MM IN DIAMETER, 40 DEGREE ANGLED AND WAS CALCIFIED PROXIMALLY. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED THERE WAS A PROXIMAL TYPE I ENDOLEAK PRESENT. A 28 MM DIAMETER ANEURX CUFF WAS IMPLANTED AND SUCCESSFULLY RESOLVED THE TYPE I ENDOLEAK. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED, AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR GALWAY NA V00473942

    Patients

    Seq Age Sex Outcome Treatment
    1 83 YR Required Intervention