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Model Number UNK-NV-AXIUM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Stenosis (2263); Convulsion/Seizure (4406)
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Event Date 07/29/2022 |
Event Type
Injury
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Manufacturer Narrative
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Iampreechakul p, wangtanaphat k, lertbutsayanukul p, siriwimonmas s.Revascularization of the internal carotid artery through the hypertrophied vasa vasorum in traumatic carotid-cavernous fistula previously treated by ligation of cervical carotid arteries: a case report.Surgical neurology international.2022;13:324.Doi:10.25259/sni_450_2022.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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Event Description
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Iampreechakul p, wangtanaphat k, lertbutsayanukul p, siriwimonmas s.Revascularization of the internal carotid artery through the hypertrophied vasa vasorum in traumatic carotid-cavernous fistula previously treated by ligation of cervical carotid arteries: a case report.Surgical neurology international.2022;13:324.Doi:10.25259/sni_450_2022.Medtronic literature review found a report of patient complications in association with axium coils.The purpose of this article was to described an extremely rare case of a 64-year-old woman who developed reconstitution of the occluded ica through hypertrophied vasa vasorum supplying recurrent traumatic carotid-cavernous fistula (tccf) previously treated by ligation of the internal and external carotid arteries.The article does not state any technical issues during use of the axium coil.The following intra- or post-procedural outcomes were noted: - the left ica proximal to the fistula which was occluded with axium detachable coils.One month after surgery, the occluded ica was revascularized through hypertrophied vasa vasorum.Cerebral angiography was obtained and revealed the remaining of severe stenosis of the proximal ica with associated vasa vasorum and reduction in shunt flow and size of the dilated draining vein along the left cerebral hemisphere.In addition, the fistula received additional supply from the contralateral ica and left va.The patient underwent an additional coiling procedure to embolize the fistula.Post embolization course of the patient was uneventful.Follow-up cerebral angiography, obtained 1 year after the second embolization, confirmed no recurrence of the fistula.The patient had recovered completely from neurological deficits and had few episodes of seizure requiring the continuation of antiepileptic drug.
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Manufacturer Narrative
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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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Event Description
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Additional information received reported that there was no problem with the axium coil.The product was failed to use because the patient was a very difficult case and complicated.The large aneurysm had very high flow.
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Search Alerts/Recalls
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