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

Catalog Number	HGB161207A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	05/20/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: 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: occlusion of device or native vessel.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.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 or Problem Description
The following information was reported to gore: on (b)(6) 2024, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® iliac branch endoprostheses.During the treatment, an internal iliac component was implanted into the right internal iliac artery.After all stent grafts were implanted, an angiography revealed a slight delayed flow in the right internal iliac artery.A selective angiography was performed from left upper arm for the right internal iliac artery and revealed no issues.No treatment was performed for the right internal iliac artery.The patient tolerated the procedure.On (b)(6) 2024, a computed tomography revealed an occlusion of the internal iliac component.As the patient was asymptomatic, no treatment was performed.The physician stated that the imaging revealed no compression of the stent graft so it would be due to poor outflow.

• 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: 19516951
• Report Number: 3013164176-2024-02098
• Device Sequence Number: 6081368
• Product Code: MIH
• UDI-Device Identifier: 00733132635320
• UDI-Public: 00733132635320
• 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: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/12/2024

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 Catalogue Number: HGB161207A
• 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: 06/03/2024
• Initial Report FDA Received Date: 06/12/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 01/17/2024
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Age: 85 YR
• Patient Sex: Male