BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1062095 · Received June 18, 2008

    Report

    Report Number
    2953200-2008-00430
    Event Type
    Injury
    Date Received
    June 18, 2008
    Date of Event
    May 30, 2008
    Report Date
    May 30, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL: RESULT: (LACK OF INFORMATION (DEVICE NOT RETURNED FOR EVALUATION). SECONDARY INTERVENTION REQUIRED.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS IMPLANTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. THE VESSEL MORPHOLOGY WAS NARROWING IN THE VESSEL AND SEVERE TORTUOSITY. THE STENT GRAFT WAS SUCCESSFULLY IMPLANTED. IT WAS REPORTED THAT UPON WITHDRAWAL OF THE STENT DELIVERY SYSTEM THE PHYSICIAN EXPERIENCED DIFFICULTIES. THE PHYSICIAN BELIEVES THE CAUSES OF THE DIFFICULTIES REMOVING THE DELIVERY SYSTEM WERE DUE TO A NARROWING IN THE VESSEL AND SEVERE TORTUOSITY IN THE ILIAC LIMB. THE PHYSICIAN INSERTED A BALLOON AND BALLOONED ABOVE AND BELOW THE DELIVERY CATHETER AND INSERTED A SHEATH AND WAS ABLE TO SUCCESSFULLY REMOVE THE DELIVERY CATHETER. 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 CARDIOVASCULAR NA V00087643

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention