It was reported that 3 months after placement of the stent, the stent was found fracture under ct image.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 description "chemotherapy (folfox) for this patient was started" and "closely reviewing the ct images in the past, the stent had already been fractured in the ct on (b)(6) 2022", it is assumed that fracture occurred due to the patient lesion's pressure, chemotherapy, peristalses of organs and other factors complexly.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.
|
On (b)(6) 2022, dxdt2212 was placed from pylorus to duodenal bulb.On (b)(6) 2022, chemotherapy (folfox) for this patient was started.In (b)(6) 2023, this event of stent fracture was found during endoscopy.Later: closely reviewing the ct images in the past, the stent had already been fractured in the ct of (b)(6) 2022.The fractured stent is still in the site, and it is determined to monitor how it will go.The event of stent fracture does not affect the patient's condition, but additional stent placement (stent-in-stent) is considered as the stenosis is still existing.There were no patient complications as a result of this event.
|