W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number TGU313110J |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Vascular Dissection (3160)
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Event Date 01/01/2022 |
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) 2016, this patient underwent endovascular treatment of a type b chronic aortic dissection using conformable gore® tag® thoracic endoprosthesis.On an unknown date in 2022, aneurysm enlargement of unknown amount was observed on computed tomography (ct) imaging.On an unknown date in 2023, distal stent graft-induced new entry (dsine) was observed on computed tomography angiography.On (b)(6) 2023, reintervention to place an additional stent graft was performed.The patient tolerated the procedure.It was reported that the distal edge of the device was implanted at a slight angle, that might have contributed the dsine.
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Manufacturer Narrative
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Upon further review and information received from the field indicating, this device was proximal and the reported dsine was at the distal aspect, making this complaint non-reportable per md24757.
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Search Alerts/Recalls
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