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 TGM282810J |
Device Problem
Insufficient Information (3190)
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Patient Problems
Hemoptysis (1887); Vascular Dissection (3160)
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Event Date 08/31/2023 |
Event Type
Injury
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Event Description
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The following was reported to gore: on (b)(6) 2023, this patient who developed chest pain due to new entry tears at both side of the pre-exist stent graft, proximal and distal, underwent an emergent endovascular treatment for distal new entry using gore® tag® conformable thoracic stent graft with active control system.The procedure was completed without any issue.On (b)(6) 2023, the patient developed hemoptysis, and new entry tear at the distal side of the device(dsine) and infection was observed.An emergent endovascular treatment was performed, an additional stent graft was placed at distally.The patient tolerated the procedure.
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Manufacturer Narrative
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H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with use of the gore® tag® thoracic endoprosthesis may include but are not limited to dissection, infection (device), and reoperation.
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