(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.(b)(4).Evaluation summary: visual inspection was performed on the returned device.The reported difficulty removing the device was not confirmed as it was based on case circumstances.The tip detachment was confirmed.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 supera instruction for use (ifu) instructs: following confirmed implantation of the supera stent, retract the thumb slide in a single motion to the starting position on the handle and rotate the system lock and deployment lock into the locked position, in line with the thumb slide.In this case, failing to retract the thumbslide and lock the system lock likely caused the reported difficulties.The investigation determined that the reported difficulties and additional treatment to remove the separated tip were user related.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 during a procedure of the left superficial femoral artery, the 4.5 x 100 mm supera stent was implanted, without issue.During delivery system removal, the thumbwheel was not locked and resistance was noted.The tip detached and traveled distally into the popliteal artery, but was retrieved using a non-abbott snare device.There was no reported adverse patient sequela or a clinically significant delay in the procedure.No additional information was provided.
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