According to the gore® dryseal flex introducer sheath instructions for use, adverse events that may occur and / or require intervention include vascular trauma (i.E., dissection, rupture, perforation, tear, etc.).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) 2023, this patient underwent an emergency endovascular treatment for a ruptured thoracic aortic aneurysm using gore® dryseal flex introducer sheath.The 20 fr sheath was inserted from the left side of the patient.The angiography after stent graft placement confirmed the left internal iliac artery occlusion.No treatment was performed and the procedure was completed.It was reported that the origin of the left external iliac artery was narrow and noted insertion difficulty of the sheath even after percutaneous transluminal angioplasty was performed.Although the access angiography did not show any issues, it was suspected that the left internal iliac artery was occluded due to dissection from the left external iliac artery to the left common iliac artery.
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