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 TGMR404015 |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 03/08/2024 |
Event Type
Injury
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Event Description
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The following was reported to gore: on (b)(6) 2023, the patient underwent an endovascular treatment of a thoracic aortic dissection using gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.It was reported that on (b)(6) 2024, the physician performed a reintervention to treat a small fenestration still filling the false lumen.The small fenestration was in the treatment area, just distal (approximately 2cm distal) to the implanted graft.The physician implanted an additional gore® tag® conformable thoracic stent graft with active control system distally to cover the fenestration.The patient tolerated the procedure.
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Manufacturer Narrative
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The gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu) states: patients should be counseled as to the possibility of subsequent reinterventions including catheter-based and open surgical conversion.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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Review of the event determined this event to be non-reportable.This medwatch will be voided/retracted.
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