(b)(4).It should be noted the gore® dryseal flex introducer sheath instructions for use (ifu) state ¿adverse events that may occur and / or require intervention include, but are not limited to, embolization (micro and macro) with transient or permanent ischemia.¿ 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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On (b)(6) 2022, the patient underwent emergency endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.During deployment of the gore® excluder® trunk-ipsilateral leg component, it was reported the device moved about 3cm distally but was successfully repositioned and corrected using the constraining system.After stent graft placement, it was reportedly confirmed that the left dorsalis pedis artery was poorly palpable.Intra-procedural angiography reportedly showed arterial occlusion in the lower limb.Percutaneous transluminal angioplasty and thrombectomy were performed to treat the occlusion.The patient tolerated the procedure.The report states that heparin was not administered intraoperatively; therefore, thrombus formation was likely to have progressed.It was also reported the possibility of thrombus dispersal due to manipulation of sheaths and stent graft components could not be ruled out.
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