(b)(4).The device was not returned for analysis.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation determined the reported difficulties and additional treatment appear to be related to operational context.It is likely that difficulty removing and stent dislodgment was due the stent becoming lodged within the heavily diseased lesion and dislodging during the attempt to remove.There is no indication of a product quality issue with respect to the design, manufacture, or labeling of the device.
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It was reported that the procedure was to a lesion in the external iliac artery.An unknown guide wire was advanced into the internal iliac artery and an 8x59mm otw omni elite stent system was advanced over the wire.Loss of support with the sheath was felt so it was advanced and at the same time the stent system was also advanced about 8mm into the incorrect artery.The internal iliac artery was heavily disease and caused the stent to become stuck.Force was used to remove the stent system, but the stent dislodged and only the stent system was removed.An attempt to snare the stent was made, but it was lodged in the artery.The right common femoral artery was accessed and the stent was crushed against the vessel wall.An unspecified otw omni elite stent was placed over the crushed stent.The procedure was successfully completed with the deployment of an unspecified absolute pro stent in the external iliac artery.There was no clinically significant delay in the procedure.No additional information was provided.
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