(b)(4).During processing of this complaint, attempts were made to obtain complete event, patient and device information.Visual and functional inspections were performed on the returned device.The stent was received partially deployed; however, the deployment issue was not confirmed, as the stent was able to be deployed without issue.A review of the lot history record revealed no manufacturing nonconformities that would have contributed to this complaint.Additionally, a review of the complaint history of the reported lot revealed no other incidents.The investigation was unable to determine a cause for the reported inability to deploy the stent.There is no indication of a product quality issue with respect to the design, manufacture or labeling of the device.
|
It was reported that during a procedure of the heavily tortuous, concentric, 90% stenosed, proximal internal carotid artery, deployment of the 9x7x30 mm xact stent system was attempted, but the stent only partially deployed.The device was removed without reported issue.A 9x9x30 mm xact stent was successfully deployed to treat the lesion and achieve good blood flow.There was no reported adverse patient effect or a clinically significant delay in the procedure.No additional information was provided.
|