The 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 event occurred in the patient post procedure and its cause was unknown.The location of the hemorrhage is distal to the aneurysm and also distal to the location of pipeline implant.Additionally, the patient's response to dual antiplatelet treatment (pru level) was not available.Intracerebral bleeding is a known risk of flow diversion procedure and is documented in the pipeline flex instruction for use.
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Medtronic received information that the patient developed aphasia post treatment of a giant aneurysm located in the left internal carotid artery in the suprasellar region.A ct image was taken and a remote hematoma was observed at the left frontal lobe 6 hours post procedure distal of the target lesion.The hematoma was located on the same side of the aneurysm; left, frontal lobe, near sylvian fissure and was 4.4 mm x 2.3 mm in size.It was reported that the hematoma was suspected to be caused by the rapid improvement of the circulation.There is no enlargement in bleeding, and the patient's condition is improving however the aphasia has not completely resolved.The patient is able to eat.The patient's condition has almost returned to her daily life.
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