BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1083429 · Received July 29, 2008

    Report

    Report Number
    2953200-2008-00610
    Event Type
    Injury
    Date Received
    July 29, 2008
    Date of Event
    May 19, 2008
    Report Date
    May 19, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (OTHER, SECONDARY INTERVENTION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. IT WAS REPORTED THAT TEN DAYS PRIOR TO THE STENT GRAFT IMPLANT, THE PT HAD AN INTERVENTION TO RESTORE BLOOD FLOW TO THE DISTAL PORTION OF THE LEG. THE VESSELS WERE SMALL IN DIAMETER, FRAIL AND THE INTERVENTION PRIOR TO THE STENT IMPLANTATION HAD WEAKENED THE VESSEL WALLS. THE STENT GRAFT WAS IMPLANTED. THE PHYSICIAN ELECTED TO MODEL THE STENT GRAFT POST DEPLOYMENT. THE BALLOON WAS INFLATED COMPLETELY WITHIN THE COMMON ILIAC CONTRALATERAL LIMB. THE FINAL ANGIOGRAM REVEALED THAT THERE MAY BE A TYPE III ENDOLEAK IN THE LAST STENT RING AND THE ILIAC WALL WAS PERFORATED. THE PHYSICIAN PLACED TWO ILIAC LIMBS TO COVERING THE POSSIBLE TYPE III ENDOLEAK AND THE PERFORATED VESSEL. 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 V00090448

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK