BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1081447 · Received July 25, 2008

    Report

    Report Number
    2953200-2008-00600
    Event Type
    Injury
    Date Received
    July 25, 2008
    Date of Event
    June 26, 2008
    Report Date
    June 26, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A TALENT ABDOMINAL STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED. THE AORTIC NECK WAS 29 MM IN DIAMETER DISTALLY AND WENT FROM 25 MM TO 27 MM THEN TO 30 OR 31 MM PROXIMALLY. THE ILIAC ARTERIES WERE SEVERELY TORTUOUS AND CALCIFIED. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED THERE WAS A TYPE 1 ENDOLEAK PRESENT. MODELING WITH RELIANT BALLOON WAS PERFORMED AND THE ENDOLEAK DIMINISHED BUT DID NOT COMPLETELY RESOLVE. THE DECISION WAS MADE TO NOT FURTHER INTERVENE AND THE DECISION WAS MADE TO EVALUATE THE PT AT THE 30 DAY FOLLOW-UP. NO ADDITIONAL CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 TALENT ABDOMINAL STENT GRAFT SYSTEM MIH MEDTRONIC CARDIOVASCULAR NA V00104045

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention