W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number PLC271000 |
Device Problems
Partial Blockage (1065); Malposition of Device (2616)
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Event Date 03/11/2024 |
Event Type
Injury
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Manufacturer Narrative
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H6: code c19 - the review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, improper component replacement.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) 2024, the patient was treated for an abdominal aortic aneurysm.The physician implanted three gore® excluder® iliac branch endoprostheses, (ceb231410a, ceb231010a, hgb161007a), and two gore® excluder® endoprostheses, (plc181000, plc271000.The physician intended to implant one of the excluders high in the flow divider of the main body, but it caused more blockage of blood flow than expected because the excluder covered the other side of the graft.The physician completed the procedure, but then brought the patient back into surgery and implanted another excluder, (plc161000), on the opposite side to the same level as the first side to remedy the issue of flow blockage.The patient tolerated the procedure.
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Manufacturer Narrative
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According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and/or require intervention include, but are not limited to, improper component placement.Corrected statement from instructions for use in h.10.Additional manufacturer narrative.
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Search Alerts/Recalls
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