It was reported that drainage failure of tld0806-6 was confirmed due to re-stenosis.It is hard to review suspected device's dhr, because the serial no was not checked.Biliary structure where stent was implanted is narrow and curvy.It is possible that the stent could be pressed by state of patient's lesion.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.It is hard to identify the exact cause since it is hard to reconstruct the situation at the time of procedure and the device was not returned and the information such as photo was not provided.However, based on the description, "the stent tld0806-6 was placed after choledochojejunostomy", it is assumed that the stent was pressed due to the strong pressure of the patient lesion and progress of disease, resulting in re-stenosis occurance.Through the user manual by taewoong, it is stated that "potential complications associated with the use of niti-s & comvi stent may include, but are not limited to: bile duct obstruction".This suspected device is not registered in the us but we will continuously monitor the same or similar customer complaints through accurate analyses.
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