Dabus g, kan p, diaz c, et al.Endovascular treatment of anterior cranial fossa dural arteriovenous fistula: a multicenter series.N euroradiology: a journal dedicated to neuroimaging and interventional neuroradiology.2021;63(2):259-266.Doi:10.1007/s00234-020-02536-3 medtronic literature review found a report of patient complications in association with onyx liquid embolic.The purpose of this article was to report a multicenter experience using endovascular embolization as the first line approach for treatment of anterior cranial fossa (acf) dural arteriovenous fistula (davf).Twenty-three patients were included (18 male and 5 female), and the mean age was 53 years.The embolic agents used included onyx, phil, and coils.At last follow-up, all patients had a modified rankin scale (mrs) 0 to 2.The article does not state any technical issues during use of the onyx.The following intra- or post-procedural outcomes were noted: - transarterial embolization, using nonadhesive liquid embolic agents was the initial strategy in 9 patients (onyx in 8 patients and phil in 1 patient), with the ophthalmic artery being the most common pedicle except for 2 patients where the middle meningeal artery was used.Of these 9 patients, 7 required additional treatment to achieve immediate angiographic cure (5 treated by transvenous approach and 2 with open surgery). - transvenous embolization using nonadhesive liquid embolic agents (onyx in 11 patients, phil in 3 patients), coils (4 patients), or combination of coils and onyx (1 patient), was used in 19 patients (14 as the initial strategy and 5 post failed transarterial approach).Of the 19 patients treated by transvenous approach, immediate angiographic cure was achieved in 17 (89.5%) after a single tv treatment session.
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G2: citation: authors: dabus, g., kan, p., diaz, c., pabon, b., andres-mejia, j., linfante, i., grossberg, j.A., howard, b.M., islak, c., kocer, n., kizilkilic, o., puri, a.S., kuhn, a.L., moholkar, v., ortega-gutierrez.Endovascular treatment of anterior cranial fossa dural arteriovenous fistula: a multicenter series.Neuroradiology: a journal dedicated to neuroimaging and inte 63(2):259-266 2021.Doi:10.1007/s00234-020-02536-3 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.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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