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

Catalog Number	PLC121200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	06/07/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2026, the patient underwent endovascular treatment using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.During the procedure, a gore® tag® conformable thoracic stent graft with active control system device, a gore® excluder® conformable aaa endoprosthesis device and gore® excluder® aaa endoprosthesis devices were used.The patient tolerated the procedure.On (b)(6) 2026, a flow limiting external iliac dissection was conducted by a cta.It was noted that the likely cause of right external iliac dissection was due to clamp injury from the iliac conduit.No implanted devices were attributed to the dissection.According to the physician, no occlusion of the device or vessel was noticed.It was reported that on (b)(6) 2026 the patient underwent the right iliac artery stenting (two grafts were implanted).The event was resolved.The patient is doing well.The physician is monitoring the patient.
Additional Manufacturer Narrative
C19: a review of the manufacturing records of the devices indicated the lots met all pre-release specifications.The devices remain implanted and are not available for analysis.It was unknown what device was used at the right side.Also was used: plc121200/ 31377841 udi# (b)(4).A gore® excluder® conformable aaa endoprosthesis device used during the procedure was reported separately.According to the physician, the likely cause of the right external iliac dissection was due to clamp injury from the iliac conduit.No implanted devices were attributed to the dissection.According to the physician, no occlusion of the device or vessel was noticed.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.

• Brand Name: GORE® EXCLUDER® AAA 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25616336
• Report Number: 3013164176-2026-03097
• Device Sequence Number: 9011750
• Product Code: MIH
• UDI-Device Identifier: 00733132618712
• UDI-Public: (01)00733132618712(17)281124
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/24/2026

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: PLC121200
• 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: 06/16/2026
• Initial Report FDA Received Date: 06/24/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/26/2025
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 67 YR
• Patient Sex: Female
• Patient Weight: 58 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White