The device was not returned for analysis.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 conclusive cause for the reported difficulties.It is possible that the entrapment of the device was caused by limited clearance in the mildly calcified artery and catheter tip was caught onto the proximal section of the stent as reported; however, this ultimately cannot be confirmed.The procedure to remove the sess from the stent with another non-abbott stent is due to case circumstances.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 performed to treat a de novo lesion in the mildly calcified popliteal artery.A non-abbott guide wire and non-abbott introducer sheath were used with a 5.5x80mm supera self-expanding stent system (sess), and the stent was implanted.During removal, the tip of the sess faced resistance with the implanted stent, so a 5x60mm non-abbott stent was implanted in the previously implanted stent, which allowed the the sess to be removed.The procedure ended the same day with good results, and there were no reports of prolonged hospitalization.There were no adverse patient sequelae and no clinically significant delay in the procedure.No additional information was provided.
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