A visual and functional analysis was performed on the returned unit.The reported partial stent deployment was not confirmed as the stent was already fully deployed and not returned.The resistance rotating the thumbwheel was confirmed.The difficult to remove was unable to be tested as it was the result of interaction with the anatomy.A review of the lot history record identified no manufacturing nonconformities issued to the reported lot that would have contributed to this event.Additionally, a review of the complaint history identified no other similar incidents reported from this lot.The investigation was unable to determine a cause for the reported difficulties.It may be possible that the distal shaft was entrapped, kinked or restricted within the anatomy (possibly over the aortic bifurcation) causing resistance between the shaft lumens preventing the thumbwheel from rotating; however, this could not be confirmed.The chatter marks and kinks noted on the distal sheath are consistent with the sheath being bent over a tight radius, further suggesting that anatomical conditions may have contributed to the difficulties encountered.The resistance noted with the anatomy during removal was likely due to withdrawing the ses with the stent partially deployed resulting in the stent being fully deployed in an unintended location.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 treat a tortuous external iliac artery.A 9.0x60mm absolute pro self-expanding stent system (sess) was advanced with a.035 unspecified guide wire and upon attempting to deploy the thumbwheel would not advance; however, the stent was partially deployed.During removal the stent met resistance with anatomy and the device fully deployed.The stent remains implanted in healthy tissue, but not at the intended site.The sess and sheath were removed and another unspecified stent was used to successfully complete the procedure.There was no clinically significant delay.No additional information was provided.
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