BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 2133482 · Received June 15, 2011

    Report

    Report Number
    2953200-2011-01152
    Event Type
    Injury
    Date Received
    June 15, 2011
    Date of Event
    May 18, 2011
    Report Date
    May 18, 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). EVALUATION RESULTS: ENDOLEAK. RESULTS/CONCLUSIONS: INSUFFICIENT INFORMATION PROVIDED; CAUSE OF THE ENDOLEAK IS UNKNOWN.

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF A 5 CM ABDOMINAL AORTIC ANEURYSM APPROXIMATELY ONE MONTH AGO. VESSEL MORPHOLOGY WAS REPORTED AS AORTIC NECK DIAMETER AT THE RENAL ARTERIES OF 21 MM; 15 MM BELOW THE RENAL ARTERY OF 25 MM, WITH A 37 MM LENGTH. IT WAS REPORTED THAT THREE DEVICES WERE IMPLANTED AND ON THE FINAL ANGIOGRAPHY VIEW AN UNKNOWN TYPE ENDOLEAK WAS SEEN. AN AORTIC CUFF WAS IMPLANTED HOWEVER THE ENDOLEAK WAS NOT RESOLVED. THE PATIENT WILL CONTINUE TO BE MONITORED. NO CLINICAL SEQUELAE WERE REPORTED AND THE PATIENT IS FINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC IRELAND NA V00830280

    Patients

    Seq Age Sex Outcome Treatment
    1 79 YR Required Intervention