Abstract objective: cyanoacrylate closure (cac) is a minimally invasive technique for the treatment of varicose veins.A recent paper reported serious adverse events (aes) associated with this use.This triggered an urgent survey to determine the incidence of aes in japan.Methods: the cac-ae survey was sent to all 1,030 institutions authorized for cac treatments.Cases performed between january 2020 and october 2023 were surveyed.Data on serious aes and mortality were collected.Results: there were 623 surveys returned.There were 16 cases of proximal deep vein thrombosis, 3 cases of pulmonary embolism (pe), and 0 cases of stroke.Deep vein occlusion due to cyanoacrylate extension was observed in 1 case.Vein resection due to infection was observed in 4 cases.There were 299 cases of localized phlebitis and/or allergic reactions requiring steroid administration.Systemic allergic reactions requiring steroid administration were observed in 66 cases.There was no anaphylaxis associated with cyanoacrylate.There was one postoperative death from pe.Conclusion: this report¿s intent is to provide real world data on serious aes following cac from japan given current concern over these events.An extensive report investigation of individual complications with analysis including causality will be provided following a full investigation separately.
|
Literature title: serious adverse events with cyanoacrylate closure of varicose veins: an initial report from a large-scale national survey in japan december 2023 annals of vascular diseases doi: 10.3400/avd.Oa.23-00106 license: cc by-nc-sa 4.0 b3 date of acceptance 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.
|