BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1080770 · Received July 23, 2008

    Report

    Report Number
    2953200-2008-00593
    Event Type
    Injury
    Date Received
    July 23, 2008
    Date of Event
    June 25, 2008
    Report Date
    June 25, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR GALWAY
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    REQUIRED SECONDARY INTERVENTION.

    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 AND THE AORTIC NECK WAS 23 - 25 MM IN DIAMETER AND IT HAD AN ANGULATION OF 30 - 40 DEGREES. IT WAS REPORTED THAT AFTER THE BIFURCATED STENT GRAFT WAS IMPLANTED THERE WAS A TYPE 1 ENDOLEAK, DUE TO INFOLDING OF THE STENT GRAFT. MODELING WITH RELIANT BALLOON WAS PERFORMED AND THAT IMPROVED THE ENDOLEAK TO SOME EXTENT, BUT DID NOT COMPLETELY RESOLVE IT. THE ENDOLEAK WAS RESOLVED BY PLACEMENT OF AN ANEURX AORTIC CUFF. NO ADDITIONAL 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 CARDIOVASCULAR GALWAY NA V00114814

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention