The following information was reported to gore: on (b)(6) 2022 , the patient underwent an emergency endovascular treatment for ruptured abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.The aneurysm size was reported to be about 80 mm.On an unknown date in (b)(6) 2022, at six-month follow-up examination confirmed a shrink of the aneurysm size (48 mm x 65 mm).On an unknown date in (b)(6) 2023 , at one-year follow-up examination confirmed re-enlargement of the aneurysm size (approximately 70 mm).Contrast-enhanced ct showed a type iii junction leak from the left leg or a possible proximal type i endoleak.Open surgery is considered and will be planned soon.
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H.6.Code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.Code b20: device remains implanted and therefore not available for direct analysis.H.6.Code d12: known inherent risk of device.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak and aneurysm enlargement, aneurysm rupture and death.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoprosthesis or delivery system: component migration.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional devices will be identified in this report: device name: gore® excluder® aaa endoprosthesis , lot # 24212699 , catalog # plc201200j , udi # (b)(4).Device name : gore® excluder® aaa endoprosthesis , lot # 24537271 , catalog # pla260300j , udi # (b)(4).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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