W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Model Number PLC231200 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Aneurysm (1708)
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Event Date 11/27/2022 |
Event Type
Injury
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Manufacturer Narrative
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Additional devices included on this report are as follows: catalog #ceb231410a/ serial #(b)(4)/ udi #(b)(4).Catalog #ceb231210a/ serial #(b)(4)/ 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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Event Description
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On (b)(6) 2018, the patient underwent endovascular treatment of bilateral iliac artery aneurysms using gore® excluder® aaa endoprostheses and gore® excluder® iliac branch endoprostheses.On (b)(6) 2022, the patient underwent reintervention for a type iii endoleak in the left common iliac artery.Reportedly, the gore® excluder® iliac branch component had separated from the contralateral leg component on the patient's left side.Aneurysm enlargement was also observed (amount unknown).It was noted that a gore representative was not present at the case.Cause of the component separation is unknown.It was reported that access was gained via the patient's arm and multiple (quantity unknown) gore® viabahn® endoprostheses and gore® viabahn® vbx balloon expandable endoprostheses were used in the patient's left internal and left common iliac arteries in a kissing technique to reline the separated devices.No gore® excluder® internal iliac component was located in the patient's left internal iliac artery.The reintervention was reportedly successful and the endoleak was successfully treated.There were no further reported issues.The patient tolerated the procedure.
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Manufacturer Narrative
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H.6.Investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration, endoleak, and aneurysm enlargement.According to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, component migration, endoleak, and aneurysm enlargement.The ifu also instructs users to visually verify that the distal contralateral leg radiopaque marker is aligned with the proximal edge of the long and short radiopaque markers of the iliac branch component prior to device deployment.Alignment of these markers will achieve an approximate 3 cm overlap.H.6.Investigation findings: code c21 updated to code c19 h.6.Investigation conclusions: code d16 updated to code d15.
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