On (b)(6) 2024, this patient underwent an emergent endovascular treatment of a descending aorta aneurysm rupture using gore® tag® conformable thoracic stent graft with active control system(ctag/ac).Reportedly, the procedure went well with all devices being implanted with no issues and patient tolerated the procedure.On (b)(6) 2024, it was reported that the patient developed paraplegia(detailed onset date unknown).It was also reported that the details of the treatment is unknown, but some kind of treatment was taken after onset and the patient is being monitored.
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H3: code "other" was selected as the medical device remains implanted.Return not possible.According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events which may require intervention and/or conversion to open repair include, but are not limited to: paraplegia.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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