W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number TGM343410J |
Device Problem
Migration (4003)
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Event Date 04/05/2024 |
Event Type
Injury
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Event Description
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On (b)(6) 2022, this patient underwent an endovascular treatment for a thoracic aortic aneurysm (saccular aneurysm) using gore® tag® conformable thoracic stent graft with active control system (ctag).After plug-embolizing the left subclavian artery, two ctags were implanted from zone 2 (proximal: tgm343410, distal: tgm343415).The patient tolerated the procedure without reported issues.On an unknown date, an unknown amount of aneurysm enlargement was confirmed.It was noted that the proximal end of the ctag has migrated distally due to the aneurysm enlargement.On (b)(6) 2024, a reintervention was performed.After bypassing bilateral axillary arteries and left common carotid artery, an additional ctag was implanted to zone 0, accompanied by a chimney graft (gore® excluder® aaa endoprosthesis) implantation to the brachiocephalic artery.The patient tolerated the procedure.
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Manufacturer Narrative
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H3: code "other" was selected as the medical device remains implanted.Return not possible.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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Manufacturer Narrative
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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 instruction for use (ifu), the potential adverse events with the use of device may include but are not limited to: aneurysm enlargement, migration, and reoperation.A2: age at the time of event is corrected from 80 to 84 years old.H6: investigation findings code is changed from c21 to c19.Investigation conclusions code is changed from d16 to d15, and d12 is added.
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Search Alerts/Recalls
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