BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT STENT GRAFT SYSTEM

    MDR report key: 2834247 · Received November 15, 2012

    Report

    Report Number
    2953200-2012-02198
    Event Type
    Injury
    Date Received
    November 15, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 23, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: INHERENT RISK OF PROCEDURE (MIGRATION, ENDOLEAK). PATIENT'S CONDITION AFFECTED EFFECTIVENESS OF DEVICE (DISEASE PROGRESSION, AORTIC NECK DILATATION, LOST TO FOLLOW-UP). CONCLUSION: DEVICE FAILURE/LACK OF EFFECTIVENESS RELATED TO PATIENT CONDITION (DISEASE PROGRESSION, AORTIC NECK DILATATION, LOST TO FOLLOW-UP).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. CURRENTLY, THERE IS DISEASE PROGRESSION RESULTING IN AORTIC NECK DILATATION AND THERE IS NO AORTIC NECK. THE AORTIC NECK DIAMETER AT THE RENAL ARTERY IS 30 MM AND DILATES TO 37 CM OVER THE NEXT 3 CM. THE PATIENT WAS LOST TO FOLLOW-UP. IT WAS REPORTED RECENTLY THAT THE BIFURCATED STENT GRAFT HAS MIGRATED 6 CM DISTALLY WITH A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO SURGICALLY REMOVE THE STENT GRAFTS FROM THE PATIENT AND CONVERT TO A CONVENTIONAL GRAFT. THE ILIAC LIMBS WERE WELL ADHERED TO THE ILIAC ARTERIES, THEREFORE, THE PHYSICIAN CUT THE STENT GRAFT TO TAKE ADVANTAGE OF THIS ILIAC LIMB FIXATION AND SEWED IN A TUBE GRAFT TO THE ILIAC LIMBS. THE EXPLANTED STENT GRAFT REVEALED THAT THERE WAS THROMBOSIS IN THE STENT GRAFT. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT STENT GRAFT SYSTEM SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT MIH MEDTRONIC IRELAND V00344596

    Patients

    Seq Age Sex Outcome Treatment
    1 00070 YR Required Intervention