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.The evaluation of the returned device confirmed the reported event.The stent graft was found to be partially deployed.The distal tip of the outer sheath was found to be perforated by stent graft struts making a complete stent graft deployment impossible.Furthermore, the outer sheath was found to be fractured.Potential contributing factors to the reported event have been considered.Previous investigations of similar complaints have been reviewed.The evaluation of the returned device showed that the stent graft could not be deployed due to stent graft struts perforating the distal outer sheath of the delivery system.This may be associated with a difficult vessel anatomy or a challenging stent placement site leading to increased friction and subsequent damage to the outer sheath.In this case, no information regarding the anatomy was provided.Insufficient flushing of the device may be another contributing factor to increased friction and subsequent device damage.On the basis of the information available and the evaluation of the sample returned, a definite root cause for the reported event could not be determined.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 of the same size." also 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." furthermore, the ifu states: "do not kink the delivery catheter or use excessive force during delivery to the target lesion." in addition, the ifu indicates that the device must be flushed with sterile saline.
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