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Model Number UNK-NV-ONYX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vasoconstriction (2126)
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Event Date 02/28/2022 |
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 subject underwent middle meningeal artery (mma) embolization for treatment of subdural hematoma.On (b)(6) 2022, during the procedure the subject had vasospasming of the right radial artery and right external carotid artery requiring intraarterial verapamil.Due to patient anatomy, onyx was not implanted as the interventionalist was not able to obtain a safe catheter position to implant onyx.And the procedure was completed.The vasospasms were possibly related to the mma embolization index procedure.Due to vessel tortuosity, onyx les was not able to be implanted into the middle meningeal artery safety therefore the procedure was stopped.
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Manufacturer Narrative
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B5.Updated with additional information received.H6.Coding updated based on available information.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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Event Description
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Additional information received reported the vasospasm was resolved by intra-arterial administration of verapamil.No patient disability was noted.Post-procedure, the patient's neurological symptoms were improving with no progression of the subdural hematoma.
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Event Description
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Additional information was received that external carotid artery vasospasm occurred during mma procedure.The clinical events committee (cec) adjudicated the event as non-serious.The event did not result in hospitalization.It was noted that the adverse event didn't result in any treatment and was treated with percutaneous intervention.The event was not associated with a seizure, there was no decline in mrs and it didn't result from a device deficiency.The outcome was recovered/resolved on (b)(6) 2022.It was noted that the onyx was not implanted.There was no medtronic catheter reported as being used.The site assessed the event as not related to the device and causally related to the study procedure.
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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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