On (b)(6) 2023, the patient underwent endovascular treatment of a thoracic aortic aneurysm using gore® tag® conformable thoracic stent graft with active control system.The distal end of the device was implanted just above the celiac artery, and the procedure was completed.On (b)(6) 2024, a reintervention was performed to treat for the distal side of device migration into the aneurysm.An additional stent graft was implanted in the distal side.The patient tolerated the procedure.The physician reported that he should have selected 2 device treatment plan rather than one device, because there must be a tendency to high spring back force with one device treatment plan.
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H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to : migration 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.
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