Medtronic received a literature articled titled 'the impact of patient sex on outcomes after endovascular treatment of aortoiliac occlusive disease'.The aim of the study was to explore the effect of patient sex on short-term and long-term outcomes after endovascular treatment for aortoiliac occlusive disease (aiod).A multicenter retrospective analysis was performed on all patients who underwent iliac artery stenting for aiod across the 3 participating sites from (b)(6), 2018 to (b)(6), 2021.Everflex stents were implanted in (b)(4), protégé stents were implanted in (b)(4) and visi-pro stents were implanted in (b)(4) , of the total (b)(4) patients.Intraoperative complications reported included dissection, rupture and residual stenosis.30-day complications included in-hospital mortality, myocardial infarction, prolonged mechanical ventilation, new arrhythmia, congestive heart failure exacerbation, stroke, acute kidney injury, transfusion, pulmonary embolism, deep vein thrombosis, access site hematoma, surgical site infection, pseudoaneurysm, thrombotic and embolic acute limb ischemia.
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The impact of patient sex on outcomes after endovascular treatment of aortoiliac occlusive disease ann vasc surg 2023; 95: 87¿94 https://doi.Org/10.1016/j.Avsg.2023.05.004 a2 average age a3 majority gender b3date of publication.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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