The pipeline device will not be returned for evaluation as it was implanted in the patient.Based on the reported information, there did not appear to have been any defect of the device during use.The cause of the event could not be determined based on the reported information.Mdrs related to this patient: 2029214-2016-00436, 2029214-2016-00883, 2029214-2016-00884.
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Medtronic received information from a clinical study that a patient had a carotid cavernous fistula (ccf) after pipeline implantation.The patient had received three pipeline device implants to treat a cerebral aneurysm.Review of the patient's three year follow-up imaging found that a small, direct ccf appeared stable.In addition, no aneurysms were filling.There was no report of patient symptoms in relation to this event.
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