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

Catalog Number	CEB231410A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	03/18/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: this patient underwent staged endovascular procedures for thoracoabdominal aortic aneurysm using gore® excluder® thoracoabdominal branch endoprosthesis (tambe device).On (b)(6), 2026, the first stage procedure was performed using gore® tag® conformable thoracic stent graft with active control system (ctag ac).Two ctag acs were implanted in the descending aorta.On (b)(6), 2026, the second stage procedure was performed.The tambe device was implanted.Gore® excluder® aaa endoprosthesis, gore® excluder® iliac branch endoprosthesis (ibe), and gore® viabahn® vbx balloon expandable endoprosthesis (vbx) were concomitantly implanted as well.On an unknown date, stent graft infection was found.Although the exact date was unknown, reportedly the infection occurred some time (not immediately) after the second stage procedure.The extent of the infection was unknown, and it was also unclear which devices were affected.Treatment with antibiotics was started.The patient outcome was unknown.The reporting physician commented as follows: it is unclear whether the infection occurred during the procedure ore postoperatively (in the icu, etc.), but if it had occurred during the procedure, it should have been detected early in the postoperative period.Since the infection was confirmed some time after the procedure, it is not considered that the infection was caused during the procedure, but uncertain.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.A review of the sterilization records indicated all lots met all pre-release sterilization 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 have not 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.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24838005
• Report Number: 3013164176-2026-02965
• Device Sequence Number: 9555834
• Product Code: MIH
• UDI-Device Identifier: 00733132635306
• UDI-Public: (01)00733132635306(17)280623
• 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: 2026
• 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): 04/10/2026

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: CEB231410A
• 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: 03/18/2026
• Initial Report FDA Received Date: 04/09/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/25/2025
• 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: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Male