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, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses and gore® dryseal flex introducer sheaths.After stent-graft placement, a type ii endoleak was observed but the physician decided to monitor the endoleak.In addition, reportedly no pulse could be felt in the patient's right foot.Angiography showed that the right artery below the knee was nearly occluded.Therefore, a thrombectomy was performed and blood flow was improved.It was reported that the intraoperative heparin use was started after deployment of the proximal side of the trunk ipsilateral leg endoprosthesis.Delayed heparin administration may have caused a thrombus occlusion.It was reported that the causal relation with dryseal sheath was not ruled out.
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