It was reported that 10 months after stent placement, in-growth occurred.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 and stent in/over-growth could occur 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 "10 months after stent placement, in-growth occurred", it is assumed that the stent in-growth occurred due to pressure of the patient lesion, peristalsis and foreign substance.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: stent occlusion, tumor in-growth".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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