It was reported that 4 weeks after placement of the stent, there were holes in the silicon.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Based on the attached photo, it is confirmed that there are holes in the placed stent.However, it is hard to exactly analyze because the device was not returned yet.Investigation will be conducted once device is returned and we will send follow-up report accordingly.
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It was reported that 4 weeks after placement of the stent, there were holes in the silicon.Based on the attached photo, it is confirmed that there are holes in the placed stent.As a result of analysis of returned device, only the stent was returned.There were foreign substances like blood on the middle of the stent, and a small hole occurred.The forceps used to remove the stent was left in the end of the stent, and there was a small hole where it was pulled.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Inspection of hole on the stent cover is performed by taewoong medical during stent coating process and half-finished product inspection process.Based on the foreign substances and hole in the stent, there is a possibility cover hole might have occurred after placement due to pressure of patient's lesion, foreign substance and body fluid, removal process, etc.Complexly.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.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: cover breakdown with ingrowth of the mucosa".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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