W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT231216J |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Obstruction/Occlusion (2422)
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Event Date 04/01/2024 |
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: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: occlusion of device or native vessel 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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On (b)(6) 2024, this patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A gore dryseal flex introducer sheath(dsf sheath) was used for access and a gore® molding & occlusion balloon catheter(mob) was used for ballooning.Reportedly, although the bilateral external iliac arteries were tortuous and the bilateral common iliac arteries were calcified, the procedure was planned to preserve the left internal iliac artery.During procedure, a poor blood flow in the left internal iliac artery was observed on the angiography, but the procedure proceeded as planned.After the right internal iliac artery was coil embolized, all devices were deployed as planned, but an iliac extender component that was deployed distally was not fully expanded due to the narrow vessel diameter approximately 5.6mm.Reportedly, even the left external iliac artery was highly tortuous, the dsf sheath was advanced without any resistance.Upon deploying a trunk-ipsilateral leg component proximal to the bifurcation of the iliac artery, ballooning by mob device was performed.The final angiography revealed the left internal iliac artery was occluded, but the procedure was completed without further treatment.The patient tolerated the procedure.The possibility was reported that there was calcification near the bifurcation of the iliac artery and that device manipulation might have dispersed it, leading to left internal iliac artery occlusion.
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