Model Number NV UNK FLEX |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Ischemia (1942)
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Event Date 10/16/2019 |
Event Type
Injury
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Manufacturer Narrative
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The device involved in the reported event will not be returned for evaluation as it was implanted in the patient; therefore, the event cause could not be determined.Correspondence has been sent out to the customer for additional information.If the additional information is received, a supplemental report will be submitted.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 report that it was observed during a six month follow up that the patient¿s left internal carotid artery (ica) was completely shut down.The patient had a complete circle of willis; therefore, they had blood flow.The patient suffered from mild dementia and mild left sided weakness.The patient had undergone embolization treatment where the medtronic flow diverter was placed in the left distal supraclinoid.
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Manufacturer Narrative
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B5.Event description - additional information.G4.Date manufacturer received - additional information.G7.Type of report - additional information.H2.Follow-up type - additional information.H10.Additional manufacturer narrative - additional 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.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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Additional information was received.The patient had the dementia prior to the procedure, but presented with the mild left sided weakness at the six month follow up.The cause of the internal carotid artery (ica) completely shutting down was unknown.It was also unknown if the patient had problems with the medication after the procedure.There were no complications at the time of the procedure.It was believed the pipeline opened properly at the time of the procedure.
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Search Alerts/Recalls
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