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 TGMR313120J |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/28/2023 |
Event Type
Injury
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Event Description
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The following information was reported to gore: on (b)(6), 2023, the patient underwent an endovascular treatment using two gore® tag® conformable thoracic stent graft with active control system (ctagac) for ulp (ulcer-like projection).On an unknown date in 2023, it was reported that the patient was in poor condition, with a suspected aortic infection and continued symptoms of esophageal fistula and diarrhea.In addition, distal stent graft induced new entry (dsine) and enlarged aneurysm were confirmed.(captured in this case).On (b)(6), 2023, the patient underwent reintervention.An additional ctag was deployed to extend the device distally.Reportedly, small distal type i endoleak remained and will be monitored.(captured by new case).The physician stated as follows: the infection might have destroyed the wall of the aorta.
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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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Emdr section h6: b, c, d codes updated to reflect results of investigation.
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