BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2130585 · Received June 14, 2011

    Report

    Report Number
    2953200-2011-01134
    Event Type
    Injury
    Date Received
    June 14, 2011
    Date of Event
    May 16, 2011
    Report Date
    May 16, 2011
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    MIH
    PMA / PMN Number
    P070007
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). EVAL RESULTS: ENDOLEAK, INSUFFICIENT INFO PROVIDED; CAUSE OF THE TYPE 1 ENDOLEAK IS UNK. EVAL CONCLUSION: INSUFFICIENT INFO PROVIDED; CAUSE OF THE TYPE 1 ENDOLEAK IS UNK.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PT FOR THE ENDOVASCULAR TREATMENT OF A 9.2 CM ABDOMINAL AORTIC ANEURYSM APPROX ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS THE AORTIC NECK DIAMETER OF 22 MM AT THE RENAL ARTERIES, AND 22 MM AT 15 MM BELOW THE RENAL ARTERY, WITH A 13 MM IN LENGTH; BILATERAL COMMON ILIAC DIAMETER OF 12 MM; BILATERAL COMMON ILIAC LENGTH OF 75 MM. IT WAS REPORTED THAT WHEN THE PHYSICIAN PERFORMED THE LAST ANGIOGRAPHY AT THE END OF THE CASE, THERE WAS A PROXIMAL TYPE I ENDOLEAK. THE PHYSICIAN ELECTED TO IMPLANT AN EXTRA LARGE PALMAZ STENT AND THE TYPE I ENDOLEAK WAS RESOLVED. NO 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 NONE MIH MEDTRONIC IRELAND NA V00830286

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention