W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT261418J |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/07/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.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, this patient underwent an endovascular treatment for an abdominal aortic aneurysm with the right common iliac artery aneurysm using gore® excluder®aaa endoprostheses.After deployment of the proximal trunk of trunk ipsilateral leg endoprosthesis, when placement of the contralateral leg, blood leakage was observed from the joint part of the handle.Due to the unexpected blood leakage, hurried deployment of the ipsilateral leg of trunk ipsilateral leg endoprosthesis was required to complete the implantation.No blood transfusion was performed.
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Search Alerts/Recalls
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