It was reported that the stent deployed very prematurely.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.Outer sheath can be stretched and detached so it can cause deployment failure if deployment was tried by force in this situation.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 impossible to identify the exact cause because the device was not returned.However, based on the description "stent deployed very prematurely", it is it is considered that delivery system was pressured due to patient's lesion during procedure and deployment was tried in that situation.It was hard to deploy due to pressure sheath, and strong resistance occurred, and there is a possibility when more force was used, it resulted in premature deployment.This complaint is assumed that it was malfunction due to pressed by patient's lesion, there will be continued to monitor the same or similar customer complaints.
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