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Satti sr, vance az, fowler d, farmah av, sivapatham t.Basilar artery perforator aneurysms (bapas): review of the literature and classification.Journal of neurointerventional surgery.2017;9(7):669-673.Doi:10.1136/neurintsurg-2016-012407.Please note that this date is based off of the date of publication of the article as the event dates were not provided in the published literature.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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Satti sr, vance az, fowler d, farmah av, sivapatham t.Basilar artery perforator aneurysms (bapas): review of the literature and cla ssification.Journal of neurointerventional surgery.2017;9(7):669-673.Doi:10.1136/neurintsurg-2016-012407.Medtronic literature review found a report of patient complications in association with a marksman catheter.The purpose of this article was to describe a patient with a unique clinical course secondary to a ruptured basilar artery perforator aneurysm (bapa) who underwent successful endovascular treatment using a previously undescribed approach with staged placement of three telescoping stents alone, to summarize the published cases of bapas with an emphasis on endovascular approaches and outcomes, and to present a proposed classification system to enable future papers to standardize descriptions.A 52-year-old man complained of acute onset ¿worst headache of his life¿.Ct of the head demonstrated extensive subarachnoid hemorrhage (sah).There was early mild to moderate hydrocephalus and global sulcal effacement.Initial ct angiography (cta) of the head and neck did not demonstrate an aneurysm or suggest a vascular source of his hemorrhage.The patient¿s mental status gradually declined, requiring intubation and transfer tertiary care neurocritical care unit.Upon arrival, he underwent urgent placement of an external ventricular drain (evd) and was a hunt hess 3, modified fisher grade 4 sah.Urgent six-vessel cerebral dsa demonstrated no evidence of an aneurysm or arteriovenousshunting.Five days after the sah, a mild new left pronator drift was noted on examination and cta showed no aneurysm; however, there was a new mild vasospasm.7-day follow-up conventional angiography was performed and again disclosed no evidence of an aneurysm or other source of sah.Despite ia infusion of verapamil the patient developed critical vasospasm on post-sah day 8, with a slightly decreased level of consciousness, but no focal neurologic change.The vasospasm demonstrated moderate improvement after ia verapamil in the anterior circulation; however, persistent basilar artery spasm required balloon angioplasty using a transform 4 mm×15 mm balloon.After balloon angioplasty of the basilar artery there was modest improvement in caliber, although the distal basilar artery was somewhat refractory to angioplasty.Additionally, on the late arterial phase, a new saccular 1.8 mm aneurysm was seen, arising from the left lateral wall of the mid-basilar artery.The aneurysm was confirmed on 3d rotational ang iography.Given the small size and wide neck of the aneurysm, no immediate intervention was performed owing to the high likelihood that endovascular treatment would require stent placement.Additional considerations included the lack of antiplatelet drugs and the presence of an evd.The next day, post-sah day 9, repeat cta confirmed the suspected basilar trunk aneurysm.Appearance of the aneurysm in the interval between the initially normal cta/dsa and repeat dsa/cta was concerning for an unstable aneurysm, and strongly suspected to be the source of the patient¿s sah.The underlying occult aneurysm was now angiographically visible.After urgent multidisciplinary review of the patient¿s clinical course and available literature the decision was made to pursue endovascular treatment.The following morning, the evd was removed and that evening treatment of the patient was started with dual antiplatelet therapy (aspirin 325 mg and plavix 75 mg).Initial endovascular treatment was performed with placement of two 4.5×22 mm overlapping enterprise self-expanding stents.Immediately after telescoping stent placement, the caliber of the distal basilar trunk improved with near occlusion of the basilar artery perforating aneurysm, although the aneurysm could faintly be seen on the late arterial phase imaging.The patient continued to receive standard dual antiplatelet therapy with daily aspirin 325 mg and plavix 75 mg.Owing to persistent filling of the aneurysm on the final angiogram despite telescoping stents, short-term cta was performed 2 days later, post-sah day 14.Cta confirmed patent stent construct and improved caliber of the distal basilar artery, but faint persistent filling in the aneurysm was still present and compatible in size and morphology with the angiogram.On post-sah day 16, after the patient was felt to be out of the ¿vasospasm window¿ and before transfer to the floor from the neurocritical care unit, repeat cta showed interval growth of the bapa despite double stent placement.Initially, placement of a third enterprise stent was attempted, but was unsuccessful owing to instability of the prowler select plus microcatheter, which prolapsed several times during attempted stent delivery.Finally, through a marksman 027 microcatheter, a neuroform ez 4 mm×15 mm stent was successfully deployed.After placement of this third telescoping stent, no filling of the aneurysm was seen.During withdrawal of the guide catheter, a <(><<)>50% non-flow-limiting iatrogenic dissection of the v2 segment of the left vertebral artery was identified and managed conservatively.Clinical examination on post-sah day 16 revealed a new right cranial nerve vi palsy as well as mild right upper and lower extremity weakness, compatible with a pontine perforating artery infarction.Stat ct head and cta demonstrated no new transcortical infarction or hemorrhage and confirmed stent construct patency.The patient completed a 21-day course of nimodipine and treatment was started with verapamil for persistent vasospasm.Mri was carried out on post-sah day 27 demonstrating a small left pontine subacute subcentimeter infarct, confirming the clinically suspected pontine perforating artery occlusion at the level of triple telescoping stents.Finally, conventional cerebral angiography was performed on post-sah day 30 before discharge, and confirmed complete occlusion of the bapa, patency of the stent construct, resolution of vasospasm, and occlusion of the cervical left vertebral artery secondary to prior iatrogenic dissection.The patient was discharged to an acute rehabilitation facility on post-sah day 31 on dual antiplatelet therapy and to home 3 weeks later.He underwent occupational and physical therapy.For 11 weeks and outpatient speech therapy for 15 weeks.At the 7-month outpatient follow-up, the patient reported no recurrent headaches and had made a complete neurologic recovery.Follow-up cta imaging at 7 months confirmed complete occlusion of the bapa and patency of the three telescoping basilar artery stents.The article does not state any technical issues during use of the marksman catheter.The following intra- or post-procedural outcomes were noted:" -a <(><<)>50% non-flow-limiting iatrogenic dissection of the v2 segment of the left vertebral artery -new right cranial nerve vi palsy -mild right upper and lower extremity weakness, compatible with a pontine perforating artery infarction.-persistent vasospasm -small left pontine subacute subcentimeter infarct, confirming the clinically suspected pontine perforating artery occlusion -occlusion of the cervical left vertebral artery secondary to prior iatrogenic dissection.
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