W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number PLC231000J |
Device Problem
No Apparent Adverse Event (3189)
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Patient Problem
Aneurysm (1708)
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Event Date 01/10/2023 |
Event Type
Injury
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Event Description
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On (b)(6) 2014, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.Reportedly, during a follow-up on an unknown date, trend toward enlargement of bilateral common iliac artery was observed.On (b)(6) 2023, it was observed on ct imaging, that the diameter of the left common iliac artery enlarged from 26.5mm to 40.8mm, and the diameter of the right common iliac artery enlarged from 21.4mm to 27.8mm.On (b)(6) 2023, reintervention took place.Additional stent grafts were placed in the left side.Because the diameter of right common iliac artery was still under 30mm, the physician elected monitor it and no treatment was performed for the right side.The patient tolerated the procedure.The fsa reported that, disease progression is the most likely cause of common iliac artery enlargement.
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Manufacturer Narrative
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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: c21 to c19.H6: d16 to d1001.
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Manufacturer Narrative
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B1: selected adverse event.
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Search Alerts/Recalls
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