The following was reported to gore: on (b)(6) 2018, the patient underwent an endovascular treatment of a proximal type i endoleak from a non-gore stent graft.A gore® tag® conformable thoracic endoprosthesis was implanted in almost same place with the previously implanted non-gore stent graft to treat the endoleak.On an unknown date, it was observed the proximal type i endoleak remained.An ascending aorta replacement and total debranching were performed to treat the proximal type i endoleak.(this event was captured in medwatch report number 2017233-2024-04828.) on an unknown date, the patient was admitted into the hospital due to a mediastinitis.It was reported that a graft infection was suspected.And the infection might have led the mediastinitis.Reportedly, no treatment is performed to the mediastinitis.(this event is captured in this medwatch.).
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B3: the actual event date s unknown, therefore 27-apr-2018 is used as the event date.H3: code "other" was selected as the medical device remains implanted.Return not possible.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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