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Model Number REACT-71 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Vasoconstriction (2126); Thromboembolism (2654)
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Event Date 09/05/2020 |
Event Type
Injury
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Manufacturer Narrative
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Refer to manufacturer report 2029214-2020-01063 for details pertaining to the related reportable event.Only patient's year of birth was reported in information received, not the full date-of-birth.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported there was an unsuccessful pass after the first and fourth passes with the solitaire.However, the final mtici score was 3 indicating revascularization was attained.There was no device malfunction alleged or identified in the reported detailed and no patient adverse event was reported.Additional information received indicated the patient experienced distal embolization to a new vascular territory and peri-interventional m3 occlusion left during the index procedure.Another 2x thrombectomy with distal embolization was performed for the event and resolved on (b)(6) 2020.Per the site, the event was probably related to the study procedure, device, catheter, and possibly related to the disease under the study.The sponsor assessment was the same as the site.Additional information received from the site reported the non-serious adverse event of mechanical vasospasm with a causal relationship to the study procedure and probable relationship to the study device and react catheter.The subject was treated with administration of nimotop.The event start and stop date was (b)(6) 2020.The study sponsor assessment was the same as site.Additional information received reported that the react-71 catheter was used for passes 5 and 6.
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Event Description
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Additional information received reported that event was reviewed again, and this time also assessed relationship with mc as possible related to mc- phenom 21.
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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.
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Search Alerts/Recalls
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