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: catalog# pla320400j, serial# (b)(6), udi (b)(4) and catalog# pla320400j, serial# (b)(6), udi (b)(4).H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak.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) 2023, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The devices were placed as aorto-uni-iliac (aui) stent grafting.The contralateral leg hole was intentionally covered by two aortic extenders.The vessel condition was not good, so balloon touch-up was performed lightly.The final angiography showed a type iiia endoleak around the contralateral leg hole.No treatment was given and a wait-and-see approach was taken.On (b)(6) 2024, a reintervention was performed for the endoleak.An endurant aui stent graft was additionally implanted to reline the excluder devices.The patient tolerated the procedure.Reportedly, there was no aneurysm enlargement but the reintervention was performed by the physician¿s judgement as he wanted to control the endoleak.
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