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 was implanted in the patient and not returned to the manufacturer for evaluation.Intraprocedural or post-procedural images were not provided for review; therefore, the reported event cannot be confirmed.The instructions for use identifies thrombosis as a potential complication associated with use of the device.
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