Medtronic received a journal article 'hypersensitivity reaction after cyanoacrylate closure of incompetent saphenous veins in patients with chronic venous disease: a retrospective study'.The objective of the study was to evaluate the incidence of, the risk factors for, the nature of the disease, and the management of hypersensitivity reaction (hsr) after cyanoacrylate closure (cac) of incompetent saphenous veins in patients with chronic venous disease.A total of 126 saphenous veins, including 106 great saphenous veins (84.1%), 7 anterior accessory saphenous veins (5.6%), and 13 small saphenous veins (10.3%) of 126 limbs from 101 patients were included.A hsr occurred in 16 of 101 patients (15.8%), in 19 of 126 limbs (15.0%), and in 19 of 126 treated saphenous veins (15.0%).Hsr-related erythema, itching, swelling, and pain occurred in 100.0%, 95.0%, 68.4%, and 52.6%, of hsr patients, respectively.Hsr occurred 1 week after cac.All hsr symptoms were mild, could be treated with nonsteroidal anti-inflammatory drugs (nsaids) and antihistamine, and were resolved within 1 week.A hsr occurred in 15.8% of patients and in 15.0% of limbs after cac.Risk factors for hsr were a suprafascial saphenous vein located close to the skin and a large saphenous vein.All hsr symptoms were mild in severity, occurred at 1 week after cac, and were resolved within 1 week after treatment with nonsteroidal anti-inflammatory drugs and antihistamines.
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Article title hypersensitivity reaction after cyanoacrylate closure of incompetent saphenous veins in patients with chronic venous disease: a retrospective study journal of vascular surgery: venous and lymphatic disorders sermsathanasawadi et al 911 volume 9, number 4 https://doi.Org/10.1016/j.Jvsv.2020.12.074 b3 date of publication a2 average age a3 majority gender.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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