The device was not returned for evaluation.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 incidents and/or complaints reported from this lot.Based on the information provided, a conclusive cause for the reported difficulties could not be determined.It may be possible that the distal sheath portion of the supera delivery system was kinked in the anatomy such that the ratchet was unable to properly engage the remaining proximal segment of stent preventing the stent from releasing; 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 reported that the procedure was to treat a lesion located in the superficial femoral artery.Dilatation was performed and the device was advanced, without resistance, to the lesion using crossover access.The stent was fully deployed, without issue, but would not detach from the system, so under fluoroscopy, the complete system was removed with the stent still attached.There was no reported adverse patient effect, and no clinically significant delay in the procedure.No additional information was provided.
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