BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1933734 · Received December 16, 2010

    Report

    Report Number
    2953200-2010-02563
    Event Type
    Injury
    Date Received
    December 16, 2010
    Report Date
    November 17, 2010
    Manufacturer
    MEDTRONIC CARDIOVASCULAR SANTA ROSA
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVALUATION: RESULTS: (STENT GRAFT MIGRATION, ENDOLEAK), (DISEASE PROGRESSION, ANGULATED AORTIC BIFURCATION, DILATED AND SHORT AORTIC NECK). CONCLUSION: (DISEASE PROGRESSION, ANGULATED AORTIC BIFURCATION, DILATED AND SHORT AORTIC NECK).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROX 7 YEARS AGO. ANEURYSM AND VESSEL MORPHOLOGY AT THE TIME OF IMPLANT WERE NOT REPORTED. IT WAS REPORTED THAT THE TALENT AORTO-UNI-ILIAC DEVICE WAS PLACED WITH A LEFT TO RIGHT FEM-FEM BYPASS. IN 2005, A PROXIMAL CUFF WAS PLACED FOR AN UNK REASON. THE PT HAS BEEN FOLLOWED BY ULTRASOUND, AND A TYPE 1 ENDOLEAK WAS IDENTIFIED; THEN, A CT SCAN SHOWED THAT THE DEVICE HAD MIGRATED INTO IN THE ANEURYSM SAC. AT THE TIME OF THE MIGRATION, THE NECK WAS FULL OF THROMBUS AND MEASURES 34MM IN DIAMETER, AND ESSENTIALLY THERE IS NO NECK LENGTH. THE AORTIC BIFURCATION IS VERY TORTUOUS AND THERE IS DISEASE PROGRESSION EXTENDING UPWARD TO THE VISCERAL VESSELS. A SURGICAL REPAIR IS PLANNED FOR A LATER DATE. NO ADDITIONAL 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 SANTA ROSA NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention