It was reported that during deployment the endovascular stent graft allegedly only partially deployed as there was no more room to continue with the pin & pull action in order to fully deploy the stent graft.Therefore, the delivery system was removed with the partial deployed stent without incident.Reportedly, two smaller size stent grafts were successfully deployed to cover the treatment area and complete the procedure.There was no reported patient injury.
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Manufacturing review: a manufacturing related cause was considered.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 the specification prior to shipment.There was no manufacturing anomalies or changes which may have caused or contributed to the reported event.Investigation summary: on the basis of the returned stent graft delivery system, the alleged partial deployment could not be confirmed as the stent graft was found completely loaded in the system.However, the reported impossibility to deploy the stent graft was confirmed.The outer sheath was found to be elongated which indicated that increased friction affected the delivery system during attempt of stent graft deployment.As a result of the investigation performed the complaint was confirmed.However, based on the available information and the evaluation of the returned sample, a definite root cause for the reported event could not be determined.Labeling review: in reviewing the labeling supplied with this product it was found that the instructions for use (ifu) sufficiently address the potential risk.The ifu states: "if unusual resistance or high deployment force is encountered during stent graft deployment, abort the procedure, remove the delivery system and use an alternative device." regarding the use of accessories the ifu states: "materials required for the fluency® plus endovascular stent graft procedure: (.) introducer sheath with appropriate inner diameter (.)" and "the use of an appropriately sized introducer sheath is recommended." furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." and "prior to loading the endovascular system over a guide wire, both ports must be flushed with sterile saline (¿).Flushing these lumens will also facilitate stent graft deployment.".
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It was reported that during deployment the endovascular stent graft allegedly only partially deployed as there was no more room to continue with the pin & pull action in order to fully deploy the stent graft.Therefore, the delivery system was removed with the partial deployed stent without incident.Reportedly, two smaller size stent grafts were successfully deployed to cover the treatment area and complete the procedure.There was no reported patient injury.
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