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See for literature article.Related to regulatory report: 2029214-2022-02175.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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Ni, jiang, xu, lei, yang, su, gu, and mao; journal of neurosurgery; 2018; 128:1813¿1822; treatment of aneurysms in patients with moyamoya disease: a 10-year single-center experience; doi: 10.3171/2017.3.Jns162290 ni, jiang, xu, lei, yang, su, gu, and mao; journal of neurosurgery; 2018; 128:1813¿1822; treatment of aneurysms in patients with moyamoya disease: a 10-year single-center experience; doi: 10.3171/2017.3.Jns162290.Medtronic received information in literature article that 34 patient¿s were treated for moyamoya disease (mmd) accompanied by intracranial aneurysms.There were 17 men and 17 women ranging in age from 11 to 67 years.Clinical presentation included subarachnoid hemorrhage (sah) in 8 patients, intraventricular hemorrhage (ivh) in 11, intracerebral hemorrhage (ich) in 3, ich with ivh in 9, sah with ich in 1, and ischemic stroke in 2.Among these patients, 2 harbored multiple aneurysms (2 aneurysms).Thus, there were 36 aneurysms in this cohort.All procedures were performed using a uniplane angiographic system with the patient under general anesthesia.Vascular access was obtained via a transfemoral approach by using a 5.0- or 6.0-fr envoy guiding catheter.With the guidance of a roadmap[1]ping technique, a microcatheter (echelon-14, echelon-10, or marathon) was navigated to the aneurysm sac¿or as close as possible to it¿in the parent artery.Detachable coils or onyx 18 were used to embolize the aneurysm or the distal parent artery as close as possible to the lesion.Surgical clipping was performed simultaneously with cerebral revascularization.An enlarged modified pterional approach was used.Results of electrophysiological monitoring, including somatosensory evoked potentials and motor evoked potentials, were recorded in all cases.Angiographic intraoperative evaluation was performed using indocyanine green video angiography.Of the 17 peripheral aneurysms, 3 were treated with selective occlusion using coils.One aneurysm was treated with onyx 18 to occlude the distal parent artery when the microcatheter approached but failed to reach the sac.The other 13 aneurysms were treated with cerebral revascularization alone, because of the inaccessible arterial approach to the aneurysms.Of the 13 main trunk aneurysms in the anterior circulation, 10 lesions were clipped with the assistance of intraoperative monitoring, followed by simultaneous cerebral revascularization, and the other 3 were treated with endovascular coiling followed by staged cerebral re[1]vascularization.Of the 6 main trunk aneurysms in the posterior circulation, 4 underwent endovascular coiling, where-as the remaining 2 were treated with pure revascularization.Results: two patients underwent indirect bypass due to the lack of a recipient artery on the brain surface.There were 3 procedure-related complications in this cohort.One coil protruded into the ica during the endovascular procedure in 1 patient who harbored an ophthalmic artery (opha) aneurysm.However, no neurological symptoms developed in this patient.An intracerebral hematoma was discovered in 1 patient with an anterior communicating artery (acoa) aneurysm 24 hours after aneurysm clipping and revascularization and was evacuated immediately.The patient displayed moderate disability at discharge, improved to mild disability at the 6-month follow-up, and recovered to normal at the 72-month follow-up.One patient with an ica bifurcation aneurysm suffered an ipsilateral basal ganglia infarction 72 hours after aneurysm clipping and edms.The patient still had moderate disability at the latest follow-up.No patient died during hospital admission.One patient who harbored a basilar apex aneurysm and underwent revascularization alone died of contralateral ich 9 months after surgery.Of the surviving 33 patients, none suffered recurrent intracranial hemorrhage, cerebral ischemia, or aneurysm rupture during the follow-up.Three patients had severe neurological deficits (mrs score 3¿5) due either to the brain damage caused by the initial ictus of intracranial hemorrhage or to a surgical complication.The remaining 30 patients attained good outcomes, with or without mild neurological deficits.
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