BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TALENT ABDOMINAL STENT GRAFT SYSTEM

    MDR report key: 1153361 · Received September 5, 2008

    Report

    Report Number
    2953200-2008-00771
    Event Type
    Injury
    Date Received
    September 5, 2008
    Date of Event
    August 11, 2008
    Report Date
    August 11, 2008
    Manufacturer
    MEDTRONIC CARDIOVASCULAR
    Product Code
    MIH
    PMA / PMN Number
    P070027
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION: RESULTS AND CONCLUSIONS: MODERATELY TORTUOUS AND CALCIFIED ARTERIES. REQUIRED SECONDARY INTERVENTION. EVALUATION SUMMARY: THE DELIVERY SYSTEM WAS RETURNED TO MEDTRONIC AND ITS EVALUATION HAS BEEN COMPLETED. THERE WERE MULTIPLE KINKS AT 118MM, 135MM, 165MM AND 200MM FROM THE END OF THE GRAFT COVER. WITH THE INVESTIGATION PERFORMED IT WAS DETERMINED THAT THE INABILITY TO ADVANCE THE DEVICE THROUGH THE VASCULATURE WAS DUE TO THE PATIENT VESSEL MORPHOLOGY.

    Description of Event or Problem · 1

    A TALENT STENT GRAFT SYSTEM WAS INSERTED IN A PATIENT FOR THE ENDOVASCULAR TREATMENT OF AN ABDOMINAL AORTIC ANEURYSM. ANEURYSM MORPHOLOGY WAS NOT REPORTED AND THE ARTERIES WERE MODERATELY TORTUOUS WITH LITTLE TO MODERATE CALCIFICATION. IT WAS REPORTED THAT THE DELIVERY SYSTEM COULD NOT BE ADVANCED THROUGH THE VASCULATURE TO ACCESS THE ANEURYSM. THE DELIVERY SYSTEM KINKED AND IT WAS REMOVED FROM THE PATIENT. A 22 FR SHEATH WAS INSERTED AND IT WAS USED TO DILATE THE VESSEL. ANOTHER TALENT DEVICE WAS SUCCESSFULLY ADVANCED AND DEPLOYED. 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 V00118752

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK