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Jaims lim, justin m.Cappuzzo, muhammad waqas, faisal almayman, jeffrey a.Fearon elad i.Levy; pediatric neurosurgery; 2022; 1-6: left ophthalmic segment internal carotid artery aneurysm treated with flow diversion in a child with apert syndrome: technical note; doi: 10.1159/000527795.Medtronic received information in a literature article of a patient treated with a pipeline stent and phenom17 catheter had complications.The article was a case presentation of a 10-year-old boy with apert syndrome who underwent elective craniofacial reconstruction for his mid-facial hypoplasia and resultant obstructive sleep apnea. subcranial le fort iii osteotomies, bilateral lateral canthopexies, and sequential dilation of nares were conducted along with application and distraction with a pediatric halo device to obtain expected and appropriate post-correction skull figuration.More specifically, osteotomies were performed along the lateral orbital rims down to the zygomatic arches bilaterally and into the orbit.This freed the floor of the orbits.Additional cuts were made along the medial orbital wall behind the lacrimal fossa and across the nasal dorsum.Lastly, a pterygomaxillary osteotomy was performed bilaterally.After all bony work was complete, the external halo distraction device was placed.Nasal dilations were performed, and the procedure was completed without any complications or intraoperative issues.Postoperatively, the patient developed a severe headache behind his left eye and difficulty with left eye movements that resolved over days and months, respectively.His 1-year follow-up brain mri revealed a left 1.5-cm circular t1 heterointense, t2 core hypointense rim-hypertense, t2 fluid-attenuated inversion-recovery (flair) heterointense lesion in the left internal carotid artery (ica) ophthalmic segment area with mass effect, medial displacement of the optic nerve, and mesial temporal lobe that was concerning for a thrombosed aneurysm, and encephalomalacia and flair signal along the frontoparietal cortex.Procedure: with the patient in a supine position, a 6-french femoral sheath was placed utilizing the seldinger technique.After verification of proper placement of the sheath, 2,500 u of heparin was administered intravenously.A benchmark 95 catheter was introduced over a berenstein select catheter over a 0.035 in exchange length wire.The left common carotid artery was selectively catheterized, and angiographic runs revealed a large (1.3 cm × 0.9 cm), irregularly shaped saccular left ica ophthalmic segment aneurysm with critical distal left middle cerebral artery (mca) stenosis.Significant pial collaterals from the left anterior cerebral artery also contributed blood supply to the mca perfusion territory.Given the critical stenosis and the mri and angiographic findings, a decision was made to treat the aneurysm with endovascular pipeline embolic device (ped) flow diversion.Open surgical alternatives were less favored given the previous craniofacial reconstruction.Due to the aneurysm¿s large neck size, irregular shape, and heterogeneous filling and the mri findings, primary coiling was less favored due to concerns of dislodging thromboses within the aneurysm, causing stroke.Accordingly, the benchmark 95 catheter was brought further up into the ica.The berenstein select catheter was subsequently removed, and a phenom 17 catheter and a synchro-2 microwire were advanced. a 3.75 mm × 18 mm ped was introduced over the pre-ophthalmic arterial segment proximally and the junction of the ophthalmic and communicating arterial segments of the ica distally.Further angiographic runs showed partial stasis and decreased flow within the aneurysm dome with no other vascular abnormality in the lateral and anteroposterior views. all catheters were removed, and the groin was closed with a 6-french angio-seal percutaneous closure device.The patient was observed overnight in the intensive care unit.Systolic blood pressure was kept strictly between 80 and 100 mm hg.Postoperatively, the patient¿s baseline neurological level was unchanged.He was discharged home the following day on aspirin (81 mg daily) and clopidogrel. post-op: the patient was well and at his neurological baseline 1 month post-procedure.He was back to his daily activities, including playing supervised baseball.At the 3-month follow-up, he was found to have some word-finding difficulty and stuttering speech.A diagnostic angiogram revealed in-stent ica stenosis that was believed to be symptomatic, and a submaximal balloon angioplasty was performed.The patient did well post-procedurally and had tremendous improvement in his stuttering speech.At the 3-month follow-up after the angioplasty, a magnetic resonance angiogram displayed severe left anterior cerebral artery and left mca stenosis.Because the patient¿s stuttering speech had worsened over the several weeks before follow-up, he was taken for submaximal balloon angioplasty of the in-stent stenosis and left mca stenosis.Views of the ica and mca area before and after the second angioplasty reveal a successful result.On follow-up examination, 1 month later, the patient had near resolution and improvement of his stuttering without an y other neurological deficits or issues.
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Event related to regulatory report: 2029214-2023-01896.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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