MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	CEB231010A
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	12/22/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2023, a patient underwent endovascular treatment of an abdominal aortic aneurysm and a right iliac aneurysm using gore® excluder® iliac branch endoprostheses, gore® excluder® aaa endoprostheses, and gore® excluder® conformable aaa endoprosthesis.During the treatment, an internal iliac component (iic) was difficult to be advanced into a right internal iliac artery.During attempts to advance the iic, an iliac branch component (ibc) was moved and the physician decided not to implant the iic.The right internal iliac artery was coil embolized.After the gore® excluder® conformable aaa endoprosthesis and a contralateral leg component as a left leg were implanted, a contralateral leg component as a bridging device and an iliac extender component were implanted to extend to a right external iliac artery.An angiography revealed a delay flow with an inserted dryseal sheath.An angiography using a surf flow needle revealed no delay flow.No further treatment was required.The patient tolerated the procedure.On december 23, 2023, the patient had buttock pain.A possible claudication was reported.A post-operative examination showed no issues with the distal blood flow.The physician decided to monitor it.The physician stated that regarding the buttock pain although there was stenosis, the flow was patent, and the blood flow was confirmed by a doppler examination, so he did not think there was ischemia.He will make careful decisions later, such as expanding the device if necessary.
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.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.
Additional Manufacturer Narrative
A review of the manufacturing records for the device verified that the lot met all pre-release specifications.Code d12: according to the gore® excluder® iliac branch endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: improper component placement, occlusion.Emdr section h6, codes c19, updated to reflect results of investigation.

• Brand Name: GORE® EXCLUDER® ILIAC BRANCH ENDOPROSTHESIS
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: kentaro okamoto ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18515219
• Report Number: 3013164176-2024-01960
• Device Sequence Number: 15342966
• Product Code: MIH
• UDI-Device Identifier: 00733132635283
• UDI-Public: 00733132635283
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/26/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/13/2026
• Device Catalogue Number: CEB231010A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/22/2023
• Supplement Date Received by Manufacturer: 12/22/2023
• Initial Report FDA Received Date: 01/15/2024
• Supplement Report FDA Received Date: 01/26/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/15/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 87 YR
• Patient Sex: Female