Device evaluated by mfr.: returned product consisted of an epic self-expanding stent system.The outer sheath, tip, inner sheath and the remainder of the device were checked for damage.It was noticed the stent was partially deployed sticking out of the distal end approximately 7mm from the distal side of the markerband.There was damage noticed on the outer sheath of the device in the form of kinks and twisting.The damage was located at 9, 11,13.5 and 15cm from the proximal side of the markerband.Inspection of the remainder of the device revealed no other damage or irregularities. the investigation conclusion is operational context as the product meets the design & manufacture specification but due to anatomical/procedural factors encountered during the procedure, performance was limited.(b)(4).
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