W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT351414J |
Device Problem
Device-Device Incompatibility (2919)
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Event Date 02/22/2023 |
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.H6: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak.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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The following information was reported to gore: on (b)(6)2015, this patient underwent an emergency endovascular treatment for ruptured abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.On (b)(6) 2023, contrast-enhanced computed tomography image revealed type iiia endoleak from the junction between the trunk - ipsilateral leg endoprosthesis and the aortic extender endoprosthesis.It was determined to monitor it.In addition, right renal artery occlusion and left renal artery stenosis were suggested out of the treatment area.On an unknown date, as a tendency to enlargement was observed, it decided to perform the reintervention.On (b)(6) 2024, the patient underwent reintervention.Additional stent graft was deployed.The patient tolerated the procedure.
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Manufacturer Narrative
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H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.
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Search Alerts/Recalls
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