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Model Number UNK-CV-SR-VAL-CAP |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Arrhythmia (1721); Stroke/CVA (1770); Pulmonary Dysfunction (2019); Renal Failure (2041); Perforation of Vessels (2135); Obstruction/Occlusion (2422); Paraplegia (2448); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Medtronic received the following information obtained from the journal article entitled: initial experience with fenestrated physician-modified stent grafts using 3d aortic templates rynio et al, j.Clin.Med.2022, 11(8), 2180; https://doi.Org/10.3390/jcm11082180 a2: mean age a3: mean gender d6a: exact date of implant unknown 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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Valiant captivia stent grafts were implanted during the endovascular treatment in patients with juxtarenal and suprarenal aortic aneurysms, type iv thoracoabdominal aneurysms, and type ia endoleak after endovascular aortic repair.The valiant grafts were physician modified using a 3d aortic template.Endurant iis stents and non mdt stents were also implanted.The following adverse events were reported: deformation, type i, ib, ii, iii and unknown endoleaks.The cause of the events are undetermined.
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Search Alerts/Recalls
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