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.If information is provided in the future, a supplemental report will be issued.
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During the index procedure a venaseal closure system was used to treat a lesion located in the great saphenous vein (gsv).The device was inspected and prepped per the ifu with no issues noted.Post procedure a case of granuloma was reported but it did not form at the cannulation point.It was noted to be about 10 cm above the cannulation site.Initially it was small collection that the physician did not believe to be related to the procedure and is managed by drainage and antibiotics.However, on further follow up, it was clear that it was connected to the vein/glue with a breach in the wall.It is planned to excise this next month.
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