|
Model Number UNK-NV-AXIUM |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Cerebral Edema (4403); Unspecified Nervous System Problem (4426); Thrombosis/Thrombus (4440)
|
Event Date 04/18/2014 |
Event Type
Injury
|
Manufacturer Narrative
|
Chavan rg, kamble rb, bonde v.Endovascular treatment in an unusual case of direct carotid cavernous fistula.The neuroradiology journal.2014;27(2):207-212.Doi:10.15274/nrj-2014-10032.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.
|
|
Event Description
|
Chavan rg, kamble rb, bonde v.Endovascular treatment in an unusual case of direct carotid cavernous fistula.The neuroradiology journal.2014;27(2):207-212.Doi:10.15274/nrj-2014-10032 medtronic literature review found a report of patient complications in association with an echelon 10 microcatheter, axium coils, and onyx.The purpose of this article was to describe a unique and unusual case of post-traumatic direct carotid cavernous fistula (ccf) with occluded proximal internal carotid artery and ccf filling from the contralateral side with retrograde cortical venous reflux.The following intra- or post-procedural outcomes were noted: - due to tortuosity, catheterization through the contralateral side was extremely difficult, especially due to use of the braided echelon catheter.After coiling the cavernous sac, the catheter position was not stable and tended to fall back into the distal ica which was also narrowed (probably kinked due to large size of the sac).- detachable axium coils were placed into the sac.The patient was then discharged and advised follow-up after two months.Two-month follow-up showed similar findings with patent fistula.Repeat treatment was done.Onyx was injected into the fistula and the cavernous sac.Check angiogram showed complete occlusion of the fistula.The patient was electively intubated and showed clinical deterioration after 12 hours with unequal pupils.Ct scan did not show any bleed or fresh structural changes.The clinical deterioration was probably due to thrombosis of a dilated temporal vein causing mass effect.Patient was anticoagulated with heparin and was aggressively managed for cerebral oedema, to which he responded and recovered fully.
|
|
Search Alerts/Recalls
|
|
|