W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
|
Back to Search Results |
|
Catalog Number HGB161007A |
Device Problem
Activation Failure (3270)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/08/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H6: code c19 - the review of the manufacturing paperwork verified that this 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.
|
|
Event Description
|
On (b)(6) 2024, the patient was treated for abdominal aortic aneurysm.After implanting several gore® excluder® aaa endoprostheses to treat the aneurysm in the aorta, the physician also wanted to extend deep into the internal iliac to treat an aneurysm in that vessel.The physician implanted a gore® excluder® iliac branch endoprosthesis, but when it was deployed, the distal end opened correctly, but the proximal end only partially opened.The deployment string had been fully pulled, but the proximal end of the graft still did not open all the way.The physician ballooned the graft, and it fully opened.The physician noted that the vessel was tortuous, and felt it may have contributed to the issue.The physician then implanted a gore® viabahn® vbx balloon expandable endoprosthesis.While deploying the device, the last stent ring did not open fully.The physician used a secondary balloon to complete full expansion of the stent graft, also causing a small perforation of the vessel.The physician coiled the hypogastric, and the issue was resolved.The patient tolerated the procedure.
|
|
Manufacturer Narrative
|
H6: investigation conclusions - revised to d16 based on engineering review of event.
|
|
Search Alerts/Recalls
|
|
|