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	TGMR403415
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/30/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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.
Event or Problem Description
On (b)(6) 2025, this patient underwent planned/staged endovascular treatment of a zone 4 descending thoracic aortic dissection and was implanted with two gore® tag® conformable thoracic stent graft with active control system devices (most proximal device tgmr403415/30110178.The patient tolerated the procedure.On (b)(6) 2025, this patient underwent a planned/staged endovascular treatment of a zone 4 descending thoracic aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device, gore® excluder® aaa endoprosthesis devices and gore® viabahn® vbx balloon expandable endoprosthesis devices.The patient tolerated the procedure.(captured as a non-complaint on tambe in (b)(4).On (b)(6) 2025, the patient presented to the hospital with back pain and chest pain.It was reported that a ct scan was performed and the patient is being worked up for a possible re-intervention.A caused was not provided.It was reported that the patient¿s blood pressure was controlled and the ¿pain¿ has subsided.On (b)(6) 2025, the patient was scheduled for endovascular treatment of an acute/subacute tevar procedure for the dissection with gore® tag® thoracic branch endoprosthesis however the patient presented with a possible gi bleed and the procedure was postponed.On (b)(6) 2025, the patient underwent second stage tevar post tambe endovascular treatment of a dissection - acute/subacute and was implanted with gore® tag® thoracic branch endoprosthesis (tbe) devices and a gore® tag® conformable thoracic stent graft with active control system (ctag-ac) devices.The patient tolerated the procedure.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23607092
• Report Number: 2017233-2025-06847
• Device Sequence Number: 21311815
• Product Code: MIH
• UDI-Device Identifier: 00733132661695
• UDI-Public: (01)00733132661695(17)271113
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 11/20/2025

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 Catalogue Number: TGMR403415
• Device Lot Number: 30110178
• 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: 10/31/2025
• Initial Report FDA Received Date: 11/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/14/2024
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 66 YR
• Patient Sex: Female
• Patient Weight: 66 KG