BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2914842 · Received January 15, 2013

    Report

    Report Number
    9612164-2013-00067
    Event Type
    Malfunction
    Date Received
    January 15, 2013
    Date of Event
    December 10, 2012
    Report Date
    December 16, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IS
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: RELATED TO OPERATIONAL CONTEXT. EVALUATION CONCLUSION: OPERATIONAL CONTEXT LEAD TO EVENT. (B)(4).

    Description of Event or Problem · 1

    THE PHYSICIAN WAS ATTEMPTING TO DEPLOY AN 8MM DIAMETER X 60MM LENGTH COMPLETE SE PERIPHERAL STENT SYSTEM TO TREAT A LESION IN THE RIGHT ILIAC OF A PATIENT. WHILE THE DELIVERY SYSTEM OF THE STENT WAS STILL IN THE PASSING THROUGH THE INTRODUCER SHEATH, THE PHYSICIAN FELT RESISTANCE TO THE DELIVERY SYSTEM, SO THE PHYSICIAN REMOVED THE DELIVERY SYSTEM OUT OF THE PATIENT AND NOTED THAT THE STENT WAS PARTIALLY DEPLOYED DESPITE THE FACT THAT THERE WAS NO ATTEMPT TO OPEN THE STENT. NO PATIENT INJURY AND NO CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION: THE DEVICE WAS RETURNED TO MEDTRONIC FOR EVALUATION. THE FIRST TWO DISTAL STENT SEGMENTS WERE EXPOSED AND DEPLOYED. INSPECTION OF THE DEVICE HANDLE CONFIRMED THE RED SAFETY CLIP WAS PRESENT ON THE RETURNED DEVICE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    23206 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0005894834

    Patients

    Seq Age Sex Outcome Treatment
    1