BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    COMPLETE SE ILIAC

    MDR report key: 2900722 · Received January 8, 2013

    Report

    Report Number
    9612164-2013-00037
    Event Type
    Malfunction
    Date Received
    January 8, 2013
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    MEDTRONIC IRELAND
    Product Code
    NIO
    PMA / PMN Number
    P090006
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SN
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION RESULTS: DEFORMATION PROBLEM. RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF THE ISSUE IS MOST LIKELY PROCEDURAL RELATED). EVALUATION CONCLUSION: RELATED TO OPERATIONAL CONTEXT (ROOT CAUSE OF THE ISSUE IS MOST LIKELY PROCEDURAL RELATED). (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE PHYSICIAN WAS TREATING A VERY TIGHT LESION IN THE ILIAC OF A PATIENT WITH LITTLE CALCIFICATION AND 80% STENOSIS. AFTER ANGIOPLASTY WITH A 6 X 80 BALLOON, THE COMPLETE SE STENT WAS TRACKED THROUGH THE 0.35'' WIRE. IT WAS REPORTED THAT THE STENT COULD NOT TRACK WELL AND IT WAS QUITE A DISTANCE FROM THE LESION. THEREFORE, IT WAS DECIDED TO TAKE OUT THE STENT AND RE-ANGIOPLASTY. IN THE PROCESS OF TAKING OUT THE STENT, THE WIRE WAS SOMEHOW STUCK AND THE STENT CATHETER COULD NOT BE REMOVED FROM THE WIRE. AND AFTER FLUSHING THROUGH THE WIRE PORT, THE WIRE DIDN'T MOVE. AFTER GIVEN A HARD TUCK, THE STENT WAS DE-SHEATHED MANUALLY OUTSIDE OF THE PATIENT AND FINALLY THE WIRE WAS ABLE TO BE REMOVED FROM THE STENT. AS THE STENT HAS ALREADY BEEN UN-SHEATHED, THE STENT CANNOT BE USED AGAIN. THEREFORE, ANOTHER STENT WAS OPENED AND USED. NO PATIENT INJURY OCCURRED AND NO CLINICAL SEQUELAE WERE REPORTED. DEVICE EVALUATION: THE HANDLE AND RED CLIP WERE SECURELY IN PLACE AND THERE WAS NO GAP BETWEEN THE HANDLE GRIP AND THE SLIDER MECHANISM. THE FIRST TWO DISTAL SEGMENTS OF THE STENT HAD PREMATURELY DEPLOYED. THE SHAFT WAS KINKED 2.2CM DISTAL TO THE STRAIN RELIEF. A 0.035'' MANDREL OR GUIDEWIRE COULD NOT BE FRONT LOADED OR BACK LOADED THROUGH THE INNER LUMEN DUE TO THE KINK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9877 COMPLETE SE ILIAC STENT, ILIAC NIO MEDTRONIC IRELAND 0006139822

    Patients

    Seq Age Sex Outcome Treatment
    1