W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number PLC141200J |
Device Problem
Contamination (1120)
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Patient Problem
Perforation of Vessels (2135)
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Event Date 12/20/2017 |
Event Type
Injury
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Manufacturer Narrative
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H6: code b20 -the device was discarded at the treating facility 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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Event Description
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The following information was reported to gore: on (b)(6) 2017, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis for abdominal aortic aneurysm.During procedure, type ii endoleak and suspected proximal type i endoleak were confirmed.On an unknown date, regular follow-up confirmed aneurysm enlargement due to type ii endoleak, duodenal fistula, and infection.On (b)(6) 2023, the stent grafts were explanted, and the patient's abdominal aorta was replaced with artificial blood vessel.
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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® excluder® aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include, but are not limited to, perforation, aneurysm enlargement, infection (e.G., aneurysm, device or access sites), genitourinary complications (fistula).
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Search Alerts/Recalls
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