Endurant ii stent grafts were implanted during the endovascular treatment of a type ia endoleak (endurant extension 36x49) and type iii endoleak (endurant iliac extension 16x24x124) in an unknown stent graft system.A sentrant sheath and reliant balloon was also used during the procedure.It was reported intraop complications included a left renal hemorrhage of an inferior segment which was resolved with superselective catheterization using a non mdt microcatheter and gluing.The completion angiography at the end of the procedure showed no residual endoleaks and patency of all target arteries.During the follow-up period, the patient underwent contrast-enhanced ultrasound (ceus) and computed tomography angiography (cta) and both imaging exams demonstrated patent stent grafts without any endoleaks.Despite the technical success, the patient died on postoperative day 59 due to respiratory complications.The cause of the renal hemorrhage, respiratory complications and death are undetermined.
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Medtronic received the following information obtained from the journal article entitled: a novel balloon-assisted technique to secure visceral catheterization during a chimney endovascular repair of a ruptured abdominal aortic aneurysm in a centenarian patient galastri1 et al, j.Vasc.Bras.22 2023 https://doi.Org/10.1590/1677-5449.202300182 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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