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.
|
Medtronic received a report that dissection occurred during the procedure at the level of the distal posterior cerebral artery after several attempts to reach the left cerebral arteria posterior.The event resolved the same day with no further treatment, intervention, or hospitalization.The event was not the result of a device deficiency. the event was assessed as caused by the procedure, and not related to the device or an underlying condition/disease.The patient was undergoing treatment for clots located in the p2 segment of the right posterior cerebral artery and the p3 segment of the left posterior cerebral artery.The patient's pre-procedure mtici score was 0, and post-procedure it was 3. the patient's mrs score was 3.Additional information was received that diagnostic imaging (head ct without contrast) result showed cortical ischemia with luxury perfusion on (b)(6) 2021.
|