The following information was reported to gore: on an unknown date, this patient underwent an emergency endovascular treatment using frozen elephant technique for chronic type b aortic dissection using two gore® tag® conformable thoracic stent graft with active control system.On an unknown date, graft infection and distal stent graft-induced new entry (dsine) were confirmed.Because the infection could not be controlled and aortic wall detachment was planned, it was decided to perform reintervention for additional stent graft placement first.On (b)(6) 2024, the patient underwent reintervention.An additional stent graft was placed to extend the device distally.The patient tolerated the procedure.
|
H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events which may require intervention and/or conversion to open repair include, but are not limited to: infection (e.G., aneurysm, device or access sites).W.L.Gore & associates, inc.(gore) is submitting this report to comply with 21 c.F.R.Part 803, the medical device reporting regulation.This report is based upon information obtained by gore, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Blank fields present on this report include required fields and fields determined to be not applicable.Blank required fields indicate that the information was not provided, was deemed unavailable or was not applicable.This report does not constitute an admission or a conclusion by fda, gore, or its associates that the device, gore or its associates caused or contributed to the event described in the report.In particular, this report does not constitute a legal admission by anyone that the product described in this report has any defects or has malfunctioned, as defined from a legal standpoint.These words are included in the report and are fixed items for selection created by the fda, to categorize the type of event solely for the purpose of reporting pursuant to part 803.This statement should be included with any information or report disclosed to the public under the freedom of information act.
|