It was reported that patient presented abdominal pain and fevers 9 days after placement and 11 days later died.Post modem showed perforation in the cbd.It is hard to review suspected device's dhr because the serial no.Was not checked.Perforation can be occurred by other company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.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 difficult to identify the exact root cause because the device was not returned, information such as photos were not provided and it is difficult to reconstruct the situation at the time of procedure.However, based on the description "post modem showed perforation in the cbd" and "could have been due to the brush", it is assumed that perforation occurred due to the strong pressure of the stenosis, procedure and other elements complexly, then the patient died due to septic shock.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: perforation." 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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