It was reported that one week after surgery, the patient had abdominal pain, half of the fractured stent was removed.Based on the attached photo, it was confirmed that the fractured half of the stent was removed, and there were foreign materials hardened on the cells of the stent.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Fracture can occur in any company's device as well as ours.It is affected by patient's lesion status, peristalsis of organs, and drug use in general.Stent can be frequently pressured due to patient's lesion status, and fracture can be possible.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, and it is difficult to reconstruct the situation at the time of procedure.However, based on the fractured half of the stent was removed, and foreign materials hardened on the cells of the attached photo, it is assumed that fracture occurred due to the patient lesion's pressure, peristalses of organs, foreign materials and other factors complexly.It is considered that this caused the patient to have abdominal pain, and was removed.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 fracture." 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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One week after surgery, the patient had abdominal pain, pain relief treatment did not work, and then spit out half of the fractured stent, and another half still remained in the stomach.
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