It was reported that upon attempting to deploy the stent in the duodenum, the white "y" shaped deployment device separated from the sheath/catheter.As a result of analysis of returned device, the outer sheath was detached and stent deployed and only the delivery system was returned.There was curve on the stent loaded part of the outer sheath.In the inner sheath, notable kinking was not observed.It was confirmed from the device history record that device had been manufactured with no significant issue and passed all the inspections successfully.Resistance can be felt due to pressure generated by patient's lesion during deployment.It can cause deployment failure if deployment is tried by force in this situation since outer sheath can be stretched and detached.However, it is hard to identify the exact root cause since it is hard to reconstruct the situation at the time of procedure.Based on the detached outer sheath and curve on the stent loaded part, it is considered that delivery system was pressured due to patient's lesion during the procedure and deployment was tried in that situation.It was hard to deploy due to pressure/curved sheath, in which concentrated the force causing strong resistance and the outer sheath was detached in the end, resulting in deployment failure.In addition, based on the stent being deployed, it is considered that the deployment test was tried outside of the patient's body after removing the delivery system, resulting in success.This complaint is assumed that it was a malfunction of the device due to the pressure of the patient's lesion, there will be continued monitoring of the same or similar customer complaints.
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