The lot history records have been reviewed with special attention to the manufacturing and inspection of this product and the product was found to have met all specifications prior to shipment.There is no indication for a manufacturing-related failure.On the basis of the condition of the returned device, a deployment failure could not be confirmed as no attempt to deploy the stent graft had been made.The stent graft was found to be completely loaded in the system and the safety clip was found properly attached.The outer sheath did not show any signs of the impact of deployment force.The distal tip of the delivery system was found significantly deformed.Reportedly, a 7 f introducer sheath was used during the procedure.During the performed patency test, the delivery system got stuck inside a 7 f introducer sheath.Potential contributing factors to the reported event have been considered.Based on the evaluation results, no deployment failure could be identified but a failure to advance the device through an introducer sheath of inappropriate size could be confirmed.As this was found to be an isolated incident, no previous investigations of similar complaints could have been reviewed.As per the product labeling information, the device requires a minimum introducer sheath size of 9 f.The ifu states: "materials required for the fluency plus endovascular stent graft procedure: introducer sheath with appropriate inner diameter." the product labeling on the packaging indicates that a minimum introducer size of 9 f should be used.
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