Model Number UNK-NV-SOLITAIRE |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Hemorrhagic Stroke (4417)
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Event Date 05/10/2023 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Medtronic received a report that a solitaire patient experienced a mild subarachnoid hemorrhage (sah) post procedure.The sah could be captured from the image report.This finding was 4 hours after the surgery.The prognosis was good, the sah was absorbed before discharge and nihss had been reduced to a score of 1.The mrs score was 0 and the nihss score that was available was 15.It was noted that the event was assessed as causally related to study procedure and possible to the device.The location of proximal face of clot 1: pre-procedure mtici score: 0.Final post-procedure mtici score: 3.The patient had recovered/resolved.
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Manufacturer Narrative
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Medtronic submits this report to comply with fda regulations 21 cfr parts 4 and 803.Medtronic has made reasonable efforts to provide 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.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.Medtronic will submit a supplemental report if additional relevant information becomes known.
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Event Description
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Additional information received reported causality assessment found sah was not related to device or therapy.
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Search Alerts/Recalls
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