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Model Number VNMC4646C95TU |
Device Problems
Leak/Splash (1354); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 11/26/2021 |
Event Type
Death
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Manufacturer Narrative
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Continuation of d10: section d information references the main component of the system.Other relevant device(s) are: product id: v nmf4640c185tu, serial/lot #: (b)(6), ubd: 26-sep-2020, udi#: (b)(4).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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Valiant navion stent grafts (vnmc4646c95tu) were implanted during the endovascular treatment of a thoracic aortic aneurysm on (b)(6) 2019.The patient had 2 existing talent thoracic stent grafts implanted approximately 8 years previously.It was reported core lab review of ct imaging for the navion devices taken on (b)(6) 2021 showed a new undetermined endoleak.The max aortic diameter was noted as 116mm.The imaging was na for aortic enlargement.No stent ring enlargement or stent ring migration was observed.The imaging was non evaluable for stent fractures due to artifact.It was reported the patient expired on an unknown date.The cause of the endoleak and death is undetermined. .
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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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Search Alerts/Recalls
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