Model Number SFR4-4-40-10 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Migration (4003)
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Patient Problems
Intracranial Hemorrhage (1891); Foreign Body In Patient (2687); Embolism/Embolus (4438)
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Event Date 03/20/2022 |
Event Type
Injury
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Event Description
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Medtronic received a report that the patient had a subarachnoid hemorrhage and distal embolization in the same vascular territory.The distal embolization required a mechanical thrombectomy using miicroadapt technique.The distal embolization could have been caused by a clot breakdown and migration during the procedure or by clot progression before procedure and after initial imaging.The subarachnoid hemorrhage event was resolved on (b)(6) 2022.The distal embolization was possibly related to the disease under study.The distal embolization was not resolved at the time of the event.The patient's nihss score was 23.The sah event was not related to the device but was possibly related to the study procedure.The sponsor assessment determined the sah event was possibly related to the procedure.The distal embolization event was possibly related to the study device react and solitaire per the sponsor assessment.The patient was undergoing treatment of the middle cerebral artery (mca), m1 right hemisphere.The pre-procedure mtici score was 0 and the post-procedure mtici score was 2b.
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Manufacturer Narrative
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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 that the distal embolization could have been caused by clot breakdown and migration during procedure or by clot progression before procedure and after initial imaging.Site assesses as possible related to procedure.Mtici 0 in 3rd row refers to clot number 2.Final mtici for clot 1 is 2b.Due to ineffective aspiration of clot 2 mtici for that pass is 0.This was not due to device deficiency.
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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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Additional information received reported that on 17-aug-2022, cec adjudicated event as causal relationship to study procedure, possible to study devices react and solitaire.
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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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Additional information was received clarifying there was a cerebral artery embolism in the same vascular territory.
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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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Search Alerts/Recalls
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