(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Evaluation summary: visual and functional inspections were performed on the returned device.The deployment issue was not confirmed as the stent was not returned and remains in the patient.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 was unable to determine a conclusive cause for the reported deployment difficulty.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 this was a procedure to treat a lesion in the heavily calcified superficial femoral artery (sfa).During deployment of the 4.5 x80 mm supera stent in the target lesion, the stent got caught on the nosecone.When the thumbslide was unlocked, the stent disengaged from the nosecone.However, as the sheath was being retracted, the stent was pulled further into the proximal sfa, inside a previously implanted stent.A balloon was used to post dilate the supera stent up against the previously implanted stent.Another self-expanding stent was used to complete the procedure.There were no adverse patient effects and no clinically significant delay during the procedure.No additional information was provided.
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