A search for non-conformance's associated with this part/lot number combination did not reveal any production-related issues relevant to the complaint that occurred during manufacturing of the device.The device was implanted in the patient and not returned to the manufacturer for analysis.Additionally, procedural images were not provided; therefore, the alleged event cannot be confirmed.The instructions for use identifies stent thrombosis and thromboembolic event as potential complications associated with use of the device.
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