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Model Number UNK-NV-FG |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Intracranial Hemorrhage (1891)
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Event Date 12/09/2023 |
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 the patient experienced intracranial hemorrhage with an onset date of (b)(6) 2023.This adverse event (ae) led to prolongation of existing hospitalization and plavix was held overnight.The patient recovered and the issue resolved on 2023-12-10.This was not related to the disease under study and did not result in new or worsening of existing neurological deficits.Did not result from device deficiency.Post-procedure mri showed a small hemorrhage in left centrum semiovale.This event did not result in congenital anomaly, death, disability, or medical intervention and was not considered life-threatening.The site assessed this event as causally related to the antiplatelet medication, not related to the study device, and possibly related to the study procedure.The patient was undergoing surgery for treatment of a saccular, sidewall left internal carotid artery (ica) c7 aneurysm with a max diameter of 6mm and a 5mm neck diameter.The aneurysm dome height was 4mm, dome width 5mm.Parent artery diameter distal to aneurysm was 4mm.Parent artery diameter proximal to aneurysm was 4mm.There was no stasis at the end of the procedure.There was complete neck coverage at the end of the procedure.Raymond and roy at the end of the procedure class 1.
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Search Alerts/Recalls
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