BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM - HYDRO

    MDR report key: 2050862 · Received April 1, 2011

    Report

    Report Number
    2953200-2011-00738
    Event Type
    Injury
    Date Received
    April 1, 2011
    Date of Event
    March 4, 2011
    Report Date
    March 4, 2011
    Manufacturer
    MEDTRONIC IRELAND
    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). RESULTS: (STENT GRAFT MIGRATION, ENDOLEAK). RESULTS & CONCLUSIONS: DISEASE PROGRESSION AND AORTIC NECK DILATATION).

    Description of Event or Problem · 1

    A TALENT STENT GRAFT WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM APPROXIMATELY 15 MONTHS AGO. ANEURYSM MORPHOLOGY AT THE TIME OF IMPLANT IS UNK. THE AORTIC NECK IS REVERSE TAPERED SHAPED RANGING FROM 22 MM - 27 MM AND HAS GOTTEN WORSE INCREASING 1 MM IN DIAMETER EVERY 3 MM SLICE OF THE CT SCAN. IT WAS REPORTED THAT RECENT FILMS SHOW THE TALENT BIFURCATED SENT GRAFT IS 3 CM BELOW THE LEVEL OF THE RENAL ARTERIES AND THERE IS A TYPE I ENDOLEAK PRESENT. THE STENT GRAFT MIGRATION WAS ATTRIBUTED TO DISEASE PROCESSING AND AORTIC NECK DILATATION. A 70 MM ENDURANT CUFF WAS PLACED AND SUCCESSFULLY RESOLVED THE STENT GRAFT MIGRATION/ENDOLEAK. 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 - HYDRO MIH MEDTRONIC IRELAND NA V00388435

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention