W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number TGU262610J |
Device Problem
Patient-Device Incompatibility (2682)
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Event Date 03/12/2024 |
Event Type
Injury
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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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Event Description
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On (b)(6) 2019, this patient underwent an emergent endovascular treatment for a descending aortic aneurysm using conformable gore® tag® thoracic endoprosthesis (ctag).Two ctags were implanted just above the celiac artery.Reportedly, the distal sealing length was short (less than 20 mm as instructed in ifu), but no endoleaks were observed at the end of the procedure.The patient tolerated the procedure.It was reported that the aneurysm has shrunken over time after the procedure.On (b)(6) 2024, a follow-up ct exam revealed the distal type i endoleak.On (b)(6) 2024, a bypass surgery was performed to secure the flow of celiac artery, superior mesenteric artery, and bilateral renal arteries.On (b)(6) 2024, two additional ctags were implanted to extend the previously implanted ctags.The distal type i endoleak was resolved.The patient tolerated the procedure.
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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: endoleak.Emdr section h6, codes c19, d15, d12 are updated to reflect the result of investigation.
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Search Alerts/Recalls
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