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 sample confirmed the reported failure to deploy the stent due to the breakage of a force transmitting component.The condition of the returned device indicates the presence of high release force.Increased friction is considered the reason for increased release force and subsequent deployment failure.Potential factors that could have led or contributed to the reported event have been evaluated.Previous investigations of similar complaints have been reviewed.The event may be related to a difficult anatomy as highly tortuous or calcified vessels may lead to increased friction and subsequent release force increase.In this case, no procedural or anatomical details were provided.The reported event also may also be use-related as rough handling of the device may lead to deformation and subsequent friction increase.Based on the information available, a definite root cause for the reported event could not be determined.The ifu states: "do not constrict the delivery system during stent deployment.If excessive force is felt during stent deployment, do not force the stent system.Remove the stent system and replace with a new unit" and "examine the stent system for any damage.If it is suspected that the sterility or performance of the stent system has been compromised, the device must not be used.".
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