The following information was reported to gore from medrio for clinical study (b)(4): on (b)(6) 2020, the patient underwent treatment for a thoracoabdominal aortic aneurysm with the gore® viabahn® vbx balloon expandable endoprosthesis being implanted in the celiac artery.On (b)(6) 2022, the physician noted that occlusion was present within the gore® viabahn® vbx balloon expandable endoprosthesis implanted within the celiac artery.The physician noted that the occlusion was likely due to median arcuate ligament compression.The physician noted that no intervention was needed.
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Cbas® heparin surface incorporates carmeda heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.A review of the manufacturing records indicated the lot met pre-release manufacturing specifications.Due to no device return, an investigation could not be performed.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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