Karas pj, north ry, srinivasan vm, et al.Endoscopic endonasal transsphenoidal direct access and onyx embolization of a dural arteri ovenous fistula mimicking a carotid-cavernous fistula: case report.Journal of neurosurgery.2021;135(3):722-726.Doi:10.3171/2020.7.Jns201737 medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to present the case of a woman with a paracavernous dural arteriovenous fistula (davf) mimicking the clinical and radiographic presentation of a carotid-cavernous fistula (ccf).Without any endovascular route available to access the fistulous connection and venous drainage, the authors devised a novel direct hybrid approach by performing an endoscopic endonasal transsphenoidal direct puncture and onyx embolization of the fistula.The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted: - selective microcatheterization of the left internal maxillary artery was performed, gaining access just proximal to the arterial feeders to the fistula.Onyx embolization of the fistulous branches was performed with the aid of a dual-lumen scepter c balloon under inflation with the goal of pushing onyx into the fistulous pouch.However, they were unable to reach the fistulous pouch with onyx, resulting in incomplete treatment of the arteriovenous fistula.Postembolization angiography revealed persistent filling of the fistula primarily from small branches arising off the internal carotid artery.After failure of the initial endovascular treatment, they devised a combined open and endovascular approach, with the goal of completely embolizing the fistulous pouch.The fistula was punctured with a 22-gauge spinal needle and onyx was proceeded to be injected under live fluoroscopy until the fistula was completely obliterated.An intraoperative transradial angiogram of the left common carotid artery confirmed that the fistula was completely obliterated.The hybrid endoscopic endonasal transsphenoidal direct puncture and embolization of the davf was successful.The patient recovered rapidly from the procedure, and their ocular symptoms promptly resolved.Their 3-month postoperative visit showed complete resolution of their symptoms with no recurrence.
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G2: citation: authors: karas, p.J., north, r.Y., srinivasan, v.M., lindquist, n.R., gallagher, k.K., burkhardt, j.-k., yoshor, d., <(>&<)> kan, p.Endoscopic endonasal transsphenoidal direct access and onyx embolization of a dural arteriovenous fistula mimicking a carotid-cavernous fistula: case report.Journal of neurosurgery 135(3):722-726 2021.Doi:10.3171/2020.7.Jns201737 earliest date of publication used for date of event no unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product no definitive conclusion can be made regarding the clinical observations.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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