W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
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Catalog Number RLT311417J |
Device Problem
Material Fragmentation (1261)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/05/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.6.Investigation findings code c21: conclusions pending results of product evaluation 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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The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.After deployment of the trunk - ipsilateral leg endoprosthesis, when the delivery catheter was withdrawn, the leading part of the catheter (guidewire shaft) was caught at the stenotic part of the left external iliac artery, separated from the delivery catheter, and remained in the patient.An attempt was made to retrieve the leading part by a snare catheter, but it was unsuccessful.A sheath dilator was used to push the leading part into the main body, after which the leading part was retrieved by a snare catheter successfully.No adverse event to the patient was reported, and the patient tolerated the reintervention.The reporting physician commented as follows: i think the leading part was caught by the calcified and stenotic area of the left external iliac artery.
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Manufacturer Narrative
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H.6.Type of investigation code b15: three images submitted for evaluation.The images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee the images provided are complete, accurate or lack alteration.Therefore, gore cannot guarantee all key findings have been captured or that the findings are accurate.Pre-implant images not available to review stenotic area in lei.Unable to confirm leading end of catheter broken on the available images.H.6.Investigation findings - code c21 updated to appropriate codes.H.6.Investigation conclusions - code d16 updated to d15.
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