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.Based on the sample condition it could be confirmed that the stent graft could not be deployed.The stent graft was found partially released.Furthermore, the outer sheath was found elongated, which indicates that increased friction affected the delivery system during attempt of stent graft deployment.Previous investigations of similar complaints have been reviewed.This type of event may be associated with a difficult patient anatomy, which led to increased friction and the subsequent partial stent graft deployment.Insufficient flushing of the device could be another contributing factor.A manufacturing related root cause was considered.Based on the sample condition no manufacturing related cause could be verified.On the basis of the available information a definite root cause for the reported failure could not be identified.The ifu states "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." regarding the anatomy of the placement site the ifu states: "the safety and effectiveness of the device when placed across a tight bend (.) has not been evaluated.Prior to stent graft deployment, ensure that the proximal (inflow) stent graft end is positioned in a straight section of the lumen to reduce the risk of higher deployment forces and possible endovascular system failure" and "do not kink the delivery catheter or use excessive force during delivery to the target lesion." furthermore, 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.".
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