It was reported that dxdt2215 was found being fractured after 3 months of stent placement, and re-stenosis occurred.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.Duodenum structure where stent was implanted is curvy.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 "the physician commented that the stent fracture (dxdt2215) might occur due to peristalsis.", it is assumed that the stent was fractured due to the patient lesion's peristalses and pressure and so on.In addition, 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.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, occlusion" 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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