W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT231214J |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
Hemorrhage/Bleeding (1888)
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Event Date 03/04/2024 |
Event Type
malfunction
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Event Description
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On (b)(6) 2024, this patient underwent an endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis during procedure, after removing the transparent knob, a large amount of blood leakage was observed from the catheter handle, which led the plan to deploy the contralateral leg first was changed, and the physician complete the deployment of ipsilateral leg in a hurry to withdraw the delivery catheter.Reportedly, no blood transfusion was required.The procedure was completed without further issue, and the patient tolerated the procedure.
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Manufacturer Narrative
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H3: code "other" was selected as the medical device was discarded at facility.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.Evaluation summary: the reported complaint of a leaky handle could not be independently confirmed from the review of the returned picture.The excluder device specification allows for some leakage prior to deployment of the device; however, neither the amount of leakage nor the cause could be determined with the available information.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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