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Model Number SFR4-6-40-10 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vascular Dissection (3160); Embolism/Embolus (4438)
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Event Date 05/10/2021 |
Event Type
Injury
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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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Medtronic received a report that during preparation with leading catheter, there was distal iatrogene embolization in the same territory treated with mechanical thrombectomy.The event was resolved (b)(6) 2021.It was assessed to be possibly related to the disease under study or procedure and not related to the device(s).The patient was undergoing surgery for a mechanical thrombectomy of the right internal carotid artery (ica) below carotid t and middle cerebral artery (mca) m1.The pre-procedure modified thrombolysis in cerebral infarction (mtici) was 2a, and post-procedure mtici was 2c.Modified rankin scale (mrs) score was 0, and national institutes of health stroke scale (nihss) was 15.Additional information received reported that the site was reporting a new event ica dissection which was noted day after procedure mri (b)(6) 2021 possible related to procedure.
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Manufacturer Narrative
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B5.Updated with additional information received.H6.Fdc/conclusion code updated based an additional information received.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 the medtronic study sponsor updated the assessment conclusion to note that the event had a causal relationship to the procedure and was possibly related to the study device.
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Search Alerts/Recalls
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