Continuation of d10: product id unk-nv-marathon; product type: ; g2: citation: authors: jackson, l., ma, a., <(>&<)> faulder, k.Retrieval of a fractured marathon microcatheter entrapped in onyx using a novel stentriever-assisted technique.Operative neurosurgery 23(4):e304-e308 2022.Doi:10.1227/ons.0000000000000305 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.G2: the country of the event is au see manufacturer report # 2029214-2023-01040 for another report from this article.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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Jackson l, ma a, faulder k.Retrieval of a fractured marathon microcatheter entrapped in onyx using a novel stentriever-assisted tec hnique.Operative neurosurgery (b)(6).2022;23(4):e304-e308.Doi:10.1227/ons.0000000000000305 medtronic literature review found a report of patient complications in association with a marathon catheter and onyx.The purpose of this article was to present the first case using a novel stentriever-assisted technique to successfully and safely retrieve a fractured microcatheter entrapped in onyx.The following intra- or post-procedural outcomes were noted: - a patient with a cognard iia + b dural arteriovenous fistula (davf) underwent onyx embolization.The marathon microcatheter became entrapped and fractured while initially attempting removal leaving ~30 cm of retained microcatheter extending from the occipital artery into the common carotid.A solitaire stentriever was used off label to capture the fractured microcatheter and then a larger caliber microcatheter was railroaded over it.Retrieval of the fractured microcatheter by the stentriever was then facilitated by counter traction on the onyx cast using the larger microcatheter.Postembolization cerebral angiogram demonstrated no complications.The patient awoke neurologically intact and had an uneventful postoperative course.
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