BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL AORTIC STENT GRAFT SYSTEM

    MDR report key: 2030397 · Received March 18, 2011

    Report

    Report Number
    2953200-2011-00678
    Event Type
    Injury
    Date Received
    March 18, 2011
    Date of Event
    February 16, 2011
    Report Date
    February 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: (ENDOLEAK), (TREATMENT OF ONLY AN ILIAC ANEURYSM). CONCLUSIONS: (TREATMENT OF ONLY AN ILIAC ANEURYSM).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR A 37 MM DIAMETER LEFT ILIAC ANEURYSM, APPROXIMATELY 1 MONTH AGO. VESSEL MORPHOLOGY WAS AN AORTIC NECK DIAMETER OF 25 MM PROXIMALLY, AND 27 MM DISTALLY. IT WAS REPORTED THAT THE BIFURCATED STENT GRAFT WAS IMPLANTED FROM THE RIGHT FEMORAL ACCESS AND THE CONTRALATERAL LIMB FROM THE LEFT, AND IN ADDITION, A STENT GRAFT LIMB EXTENSION WAS IMPLANTED ON THE IPSILATERAL SIDE. THERE WAS NO ENDOLEAK NOTED POST IMPLANT. EIGHT DAYS LATER, A FOLLOW-UP CT WAS DONE AND REVEALED A TYPE 1A ENDOLEAK. THE PHYSICIAN ASSESSED THAT IT IS POSSIBLE THAT THE ENDOLEAK OCCURRED BECAUSE THE BAR OF THE MAIN BODY DID NOT FIT THE CURVATURE, SEALING WAS NOT SUFFICIENT. AN INTERVENTION HAS BEEN PERFORMED; HOWEVER, THE DETAILS ARE NOT AVAILABLE. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL AORTIC STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00821818

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK