Cdt2206 was applied to a patient's sigmoid colon.Physician encountered no resistance during the deployment and no resistance during delivery system removal either.After implanted, physician admitted stent cell on the proximal end somehow deformed.Cdt2206 implanted lesion is confirmed patent, this patient is now kept under a follow-up.No patient complications reported so far as a result of this event.
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Since the device was not returned, it is impossible to proceed to actual evaluation.But, it is confirmed from the device history record that the suspected device had been manufactured with no significant issue and passed all the inspections.It is hard to find out exact root cause for this complaint, because the suspected device was not returned and it is difficult to reconstruct the situation at that time in the lab and limited info.We will continuously monitor whether similar or same complaint occurs.
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