|
Model Number SFR4-6-40-10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
|
Patient Problems
Foreign Body In Patient (2687); Embolism/Embolus (4438)
|
Event Date 06/01/2022 |
Event Type
Injury
|
Manufacturer Narrative
|
If information is provided in the future, a supplemental report will be issued.
|
|
Event Description
|
Medtronic received a report that there was distal embolization within the same vascular territory during the procedure.The patient was undergoing treatment of a stroke.The stroke onset was (b)(6) 2022 at 7:00 and reperfusion was (b)(6) 2022 at 16:35.
|
|
Event Description
|
Additional information received reported that the distal embolization recovered/resolved on (b)(6) 2022 with no additional treatment or hospitalization.The event was not a recurrent or new stroke, and was not the result of a device deficiency.The patient's mrs score was 0, and their nihss score was 18.The site assessed the event as probably related to the disease under study and an underlying condition/disease, caused by the procedure, and not related to the device.The sponsor assessed the event as caused by the procedure and possibly related to the device.The patient was undergoing treatment for a stroke located in the m2 segment of the right middle cerebral artery.The patient's pre-procedure mtici score was 0, and post-procedure it was 2b.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|