BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1062892 · Received June 19, 2008

    Report

    Report Number
    2953200-2008-00444
    Event Type
    Injury
    Date Received
    June 19, 2008
    Date of Event
    June 2, 2008
    Report Date
    June 2, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL, RESULTS AND CONCLUSION: (NARROWING/TIGHT AREA IN THE ILIAC ARTERY). OTHER, SECONDARY INTERVENTION.

    Description of Event or Problem · 1

    TWO TALENT BIFURCATED STENT GRAFT DELIVERY SYSTEMS WERE INSERTED INTO A PT FOR ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY IS UNK. VESSEL MORPHOLOGY WAS REPORTED HAVE A NARROWING/TIGHT AREA IN THE ILIAC ARTERY. IT WAS REPORTED THAT THE PHYSICIAN ATTEMPTED TO ADVANCE THE STENT GRAFT DELIVERY SYSTEM HOWEVER, DURING THE ADVANCEMENT, THE DELIVERY SYSTEM KINKED DUE TO THE NARROWING OF THE VESSEL. THE DEVICE WAS REMOVED FROM THE PT WITHOUT INCIDENT. THE PHYSICIAN THEN ATTEMPTED ANOTHER BIFURCATED STENT GRAFT SYSTEM, HOWEVER, THE SAME RESULTS AS THE FIRST DELIVERY CATHETER OCCURRED. THE STENT GRAFT DELIVERY SYSTEM WAS REMOVED FROM THE PT. (MFR # 2953200-2008-00445) THE PHYSICIAN ELECTED TO PLACE AN ANEURX STENT GRAFT AND IT WAS SUCCESSFULLY DEPLOYED. THE DELIVERY SYSTEMS WERE DISCARDED BY THE USER FACILITY. 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 MIH MEDTRONIC CARDIOVASCULAR NA V00100392

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention