Visual and functional analysis was performed on the returned device.The reported difficulties were unable to be confirmed as the stent was already fully deployed.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 revealed no other similar complaints.The investigation was unable to determine cause for the reported difficulties.It may be possible that the distal shaft was bent or restricted in the anatomy preventing the shaft lumens from moving freely and causing the resistance with the thumbwheel; however, this could not be confirmed.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 a reported that the procedure was to treat a lesion located in the proximal superficial femoral artery.Access to the vessel was obtained via antegrade approach, right superficial artery using 6f 45 cm sheath.The handle was unlocked.The physician went to rotate the thumbwheel with great resistance, and the stent began to un-flower so he kept rotating to fully deploy the stent.The physician stated there was lots of resistance with the thumbwheel; however, the stent was successfully deployed in the correct location.There were no reported adverse patient effects and no clinically significant delay in the procedure.No additional information was provided.
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