BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2971503 · Received February 21, 2013

    Report

    Report Number
    9612164-2013-00193
    Event Type
    Malfunction
    Date Received
    February 21, 2013
    Date of Event
    October 25, 2012
    Report Date
    January 22, 2013
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    RESULTS: UNAPPROVED USE OF DEVICE (DEVICE USED IN THE SFA); NO RESULTS AVAILABLE SINCE NO EVALUATION PERFORMED (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). CONCLUSION: UNABLE TO CONFIRM COMPLAINT (DEVICE OR PROCEDURAL IMAGES NOT PROVIDED FOR REVIEW). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT A PHYSICIAN HAD SUCCESSFULLY DEPLOYED AN 8MM DIAMETER X 80MM LENGTH COMPLETE SE PERIPHERAL STENT TO TREAT A LESION IN THE SFA WITH IN A IT WAS REPORTED THAT WHEN SURGEON TRIED TO REMOVE THE DELIVERY SYSTEM, THE TIP OF THE STENT SHEATH GOT STUCK INTO THE STENT CELLS. IT WAS REPORTED THAT THE SURGEON TRIED SEVERAL TIMES TO UNSTICK THE SHEATH AND FINALLY MANAGED TO DO SO AND REMOVED THE STENT FROM THE PATIENT WHEN THE SHEATH WAS REMOVED. A NEW STENT WAS IMPLANTED INTO THE PATIENT BECAUSE THE FIRST ONE WAS REMOVED. NO PATIENT INJURY AND CLINICAL SEQUELAE WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    77424 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0006191909

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention