W. L. GORE & ASSOCIATES, INC. CONFORMABLE GORE® TAG®THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number TGU312610J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Vascular Dissection (3160)
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Event Date 04/03/2024 |
Event Type
Injury
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Event Description
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The following information was reported to gore: on (b)(6) 2014, this patient underwent endovascular treatment for type b aortic dissection using conformable gore® tag® thoracic endoprostheses.The patient tolerated the procedure.On an unknown date, a follow-up examination showed a distal stent graft-induced new entry tear (dsine) of the distal ctag device.On (b)(6) 2024, a reintervention was performed.An additional stent graft was implanted in the distal side of the initial device and covered the dsine.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 could not be performed as a valid lot number was not provided.Emdr section h6, codes c21, d16 updated to reflect results of investigation.
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Search Alerts/Recalls
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