A search for non-conformances associated with the reported part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device remains implanted in the patient.Therefore, the physical device was not returned for evaluation, so the investigation could not determine if a condition existed that would have caused or contributed to the reported event.A set of procedure images were provided for in place of a product return.The review of the provided images found no evidence of stent malfunction.The narrowed stent conforms itself to the described focal narrowing of the artery just proximal and just distal to the aneurysm neck and is well apposed.The thrombosis is consistent with occurring due to the diminutive size of the artery at that narrowed segment (<2mm diameter).The instructions for use (ifu) identifies stent thrombosis as a potential complication associated with use of the device.
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