It was reported that approximately 12 days after stent placement, the stent had fractured in the middle and the tumor was coming through the break in the nitinol inside the stent causing a blockage on oesophagus.Through the attached photo, it is confirmed that the stent middle part was partially fractured, and foreign substance was attached on the cover.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 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.Esophageal structure where stent implanted is the part with active peristalsis.Stent can be frequently pressured due to patient's lesion status, and fracture 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 hard to identify the root cause since it is difficult to reconstruct the situation at the time of procedure, and the suspected device was not returned.However, based on the description, which was written that "approximately 12 days after stent placement, the stent had fractured in the middle and the tumor was coming through the break in the nitinol inside the stent causing a blockage on oesophagus.", and the confirmation that the foreign substance was attached on the cover, it is assumed that the stent was fractured due to the patient lesion's peristalses and pressure, and foreign substance such as foods, body fluids and so on.And the tumor was in growth inside the fractured part of stent due to the strong pressure of patient's lesion.Then, it is considered that the patient was unwell and vomiting since the esophageal was partially blocked by in-grown tumor.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, tumor in-growth, reflux".This complaint is assumed that it was malfunction for device due to pressure of patient's lesion, there will be continued to monitor the same or similar customer complaints.
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