W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RMT231218J |
Device Problem
Material Deformation (2976)
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Patient Problem
Stenosis (2263)
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Event Date 02/02/2024 |
Event Type
Injury
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Event Description
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The following was reported to gore: on (b)(6) 2013, the patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A trunk ipsilateral leg endoprosthesis, a contralateral leg endoprosthesis (pxc121210j) which was implanted in the right external iliac artery to extend the ipsilateral leg and a contralateral leg endoprosthesis (pxc201400j) which was implanted in the left common iliac artery were implanted.On an unknown date, the left internal iliac artery aneurysm and a stenosis without any symptoms of the trunk ipsilateral leg at around the right terminal aorta were observed.Reportedly, the stenosis was seemed like a kink/bent of the endoprosthesis.The left internal iliac artery was not treatment area of the initial gore® excluder® aaa endoprostheses.On (b)(6) 2024, a reintervention was performed.For the left internal iliac artery aneurysm, the left internal iliac artery aneurysm was embolized and then two contralateral leg endoprostheses were implanted from about the terminal aorta to the left external iliac artery.For the stenosis of the trunk ipsilateral leg at around the right terminal aorta, poba was performed to the stenosis site and then a bare stent was implanted.The patient tolerated the procedure.The physician stated that it might have been related to the stenosis of the endoprosthesis that the patient's lower back became bent over.
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Manufacturer Narrative
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B3: the actual event date is unknown, therefore (b)(6) 2024 is used for the event date.H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code b15: the image(s) received cannot be used to perform an imaging evaluation due to the insufficient data and/or poor quality of the image(s) provided.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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