MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGMR404010
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/29/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported the following to gore: on (b)(6) 2022, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® tag® conformable thoracic stent graft with active control system (ctag) 37 x 15.The physician sealed the aneurysm conservatively, with no endoleak noted.The patient tolerated the procedure.On an unknown date, a type 1a endoleak was identified.On (b)(6) 2023, reintervention (b)(4) was performed to address the type 1a endoleak in zone 3, with proximal extension using a ctag 40 x 10.The patient tolerated the procedure.On an unknown date, proximal thoracic aortic degeneration was observed.On (b)(6) 2024, a second reintervention (b)(4) occurred.Another ctag 37 x 15 was deployed proximally, and a ctag 45 x 20 was used to bridge into the previous ctag 40 x 10 implanted.On (b)(6) 2025, the patient was noted to have a type 1a endoleak and possible type 1b endoleak.On (b)(6) 2025, an emergent endovascular intervention (b)(4) was performed.Another ctag 40 x 10 was deployed proximally with intentional coverage of the left subclavian artery (lsa).Due to access limitations, a distal ctag could not be placed proximal to the celiac artery, and a 24 fr dryseal could not be advanced.The possible type 1b endoleak was not significant enough to intervene on according to the angiogram.No reintervention has occurred on the type 1b endoleak.The patient's thoracic aorta has exhibited progressive proximal degeneration, with each return visit showing growth beyond the existing graft coverage.Captured 5000 - other and 1003 - e due to rapid proximal aortic degeneration.
Additional Manufacturer Narrative
H6: code e2402 - captured for thoracic aortic degeneration.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.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22609590
• Report Number: 3007284313-2025-04140
• Device Sequence Number: 5494129
• Product Code: MIH
• UDI-Device Identifier: 00733132646838
• UDI-Public: (01)00733132646838(17)250403
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/03/2025

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: 04/03/2025
• Device Catalogue Number: TGMR404010
• 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: 08/29/2024
• Supplement Date Received by Manufacturer: 09/03/2025
• Initial Report FDA Received Date: 07/25/2025
• Supplement Report FDA Received Date: 09/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/05/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 77 YR
• Patient Sex: Female