H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use, complications associated with the use of the gore® excluder® aaa endoprosthesis that may occur and/or require intervention 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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The following information was reported to gore: on (b)(6) 2024, this patient underwent an endovascular treatment for an iliac artery aneurysm using gore® excluder® aaa endoprostheses.The left distal side of the trunk ipsilateral leg (rlt231218), which was implanted covering the left external iliac artery, migrated towards the proximal side while inflating a gore® molding and occlusion balloon.An iliac extender (pll161007) was implanted into the right external iliac artery.They checked the blood flow in the lower limb after implanting the devices.Blood pressure in the left limb was lower by 30 than in the right limb.The angiography determined a kinked stenosis in the distal side of the iliac extender (pll161007).A bare metal stent was implanted additionally as a treatment.The procedure was completed after confirming that the blood pressure difference had disappeared.The patient is doing well.Physician¿s comment: blood flow was improved with bare metal stent implantation.
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