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Model Number UNK-NV-ECHELON |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Nervous System Problem (4426)
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Event Date 08/01/2015 |
Event Type
Death
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Manufacturer Narrative
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Ni h, zhao l-b, liu s, jia z-y, cao y-z, shi h-b.The safety and efficacy of endovascular treatment for very small ruptured anterior communicating artery aneurysms: a large single-center experience with 81 consecutive cases.World neurosurgery.2021;152:e576-e582.Doi:10.1016/j.Wneu.2021.06.025.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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Ni h, zhao l-b, liu s, jia z-y, cao y-z, shi h-b.The safety and efficacy of endovascular treatment for very small ruptured anterior communicating artery aneurysms: a large single-center experience with 81 consecutive cases.World neurosurgery.2021;152:e576-e582.Doi:10.1016/j.Wneu.2021.06.025.Medtronic literature review found a report of patient complications in association with echelon microcatheters.The purpose of this article was to investigate the safety and efficacy of endovascular embolization for very small ruptured anterior communicating artery (acoma) aneurysms.From august 2015 to june 2020, 81 patients with very small (less than 3 mm) ruptured acoma aneurysms treated endovascularly were enrolled in this study.Clinical and radiographic data were analyzed retrospectively, including the aneurysm occlusion rate, complications, and clinical outcome.The article does not state any technical issues during use of the echelon microcatheter.The following intra- or post-procedural outcomes were noted: -8 patients passed or had severe disability.Death in the 4 patients was due to the severe neurologic damage with the high hunt-hess grade of 5 at admission.Of the 4 patients with neurological dysfunction, in 3 patients this was caused by postoperative delayed vasospasm and in 1 patient it was due to neurologic deficit before the procedure -twenty patients had near-complete occlusion and 2 patient had incomplete occlusion.Of the 2 residual aneurysms of immediate postop erative angiography, 1 had progressed to complete occlusion and the other had evolved a neck remnant -13 patients received an alternative check with ct angiography or magnetic resonance angiography without the incidence of recurrence -procedural complications occurred in 2 patients (2 of 81, 2.5%; both thromboembolic complications) without permanent neurologic dysfunction.-one patient was complicated with the clearance of hematoma after the coiling procedure.-the ventricular drainage tube was placed in 4 patients.
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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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New information was received.The adverse event involved in this article have no issues related to the quality of medtronic products.
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Search Alerts/Recalls
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