A search for non-conformance's 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.A procedure video was provided for review; however, the fred stent was not clearly visible.A slight filling defect is noted in the proximal parent artery.The device was implanted in the patient and not returned to the manufacturer for analysis; therefore, the alleged product issue cannot be confirmed.The instructions for use (ifu) identifies vessel occlusion and vessel stenosis or thrombosis as potential complications associated with use of the device.
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It was reported that after the fred was deployed to treat a right internal carotid artery (ica) aneurysm, an occlusion of the ica occurred.A separation ("floating") of the inner layer of the proximal stent was identified by angiography.Another stent was implanted to overlap the fred.The patient was asymptomatic and there was no reported sequela.One-week post-procedure, an occlusion within the stent was identified by mri imaging.No intervention was performed.The patient was asymptomatic and there was no reported sequela.The patient's condition was reported to be "not serious.".
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