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Model Number MAP-1000EU |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Thromboembolism (2654); Vascular Dissection (3160)
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Event Date 11/21/2022 |
Event Type
Death
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Event Description
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Medtronic received information that a patient treated with a sfr4 solitaire stent, react-68 catheter, and phenom 21 catheter had a distal thromboembolism in treated vascular territory.Thrombus in the m3 segment of a frontoparietal and parietal branch of the middle cerebral artery.Nihss score: 9, mrs score: 1.Probably thrombus not fully integrated in stent retriever, parts of it broke off during retrieval, which then moved more distally.Possibly there was not enough aspiration power to prevent distal embolism.No actions were taken.The event is resolving.Conservatively assessing the use of phenom with a possible causality to the distal embolization.The patient was being treated for a clot in the middle cerebral artery (mca), m1 left hemisphere. pre-procedure mtici score: 0.Final post-procedure mtici score: 2c.Additional information received reported that the adverse event did not result in any treatment.The site assessed the event as caused by the procedure.Additional information received reported that the patient had a new thrombectomy procedure two days later on (b)(6)2022, where it was observed that there was evidence of a left ica dissection.The patient experienced a recurrent stroke for which the patient was hospitalized.The patient was given palliative sedation and passed away on (b)(6) 2022.The event was not the result of a device deficiency.A riptide aspiration pump and stryker flowgate 2 balloon catheter had also been used.The site assessed this adverse event as caused by the disease under study, and not related to an underlying condition, the procedure, or any of the devices.The sponsor assessed the event as possibly related to the procedure due to the evidence of dissection.
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Manufacturer Narrative
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See manufacturer reports # 2029214-2022-02046, 2029214-2022-02047, and 2029214-2022-02048 for additional reports from this event.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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