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	TGMR404020
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/22/2025
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
The field sales associate (fsa) reported the following to gore: on (b)(6) 2025, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® tag® conformable thoracic stent graft with active control system (ctagac).On (b)(6) 2025, a reintervention was performed to address a type 1a endoleak utilizing the gore® tag® conformable thoracic stent graft with active control system.During the procedure, the initial deployment attempt was unsuccessful.The physician proceeded to open the hatch and employed the back-up deployment mechanism, which resulted in successful deployment.An attempt was made to angle the device downward, resulting in slight movement; however, the exact distance of displacement is unknown.Subsequently, an additional ctagac device was implanted and deployed successfully.The type 1a endoleak was resolved.
Additional Manufacturer Narrative
Added b5, g3/g4, h1/h2.
Event or Problem Description
On (b)(6) 2025, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® tag® conformable thoracic stent graft with active control system (ctagac).On (b)(6) 2025, a reintervention was performed to address a type 1a endoleak utilizing the gore® tag® conformable thoracic stent graft with active control system.During deployment of the first (distal) ctagac, the primary deployment line disconnected from the handle immediately after deployment initiation.Prior to opening the access hatch, secondary deployment was initiated and the secondary deployment line was removed, leaving the device fully constrained.Once the access hatch was opened and the primary deployment line was removed, the device expanded to its full diameter.Minor distal bird-beaking was observed, prompting the physician to perform ballooning using a gore® tri-lobe balloon, which successfully improved wall apposition.It was noted that an attempt was made to angle the device downward, resulting in slight movement; however, the exact distance of displacement is unknown.A second (proximal) ctagac was then deployed to enhance the seal at the proximal extent of the treatment zone, with no issues reported during deployment.Notably, angulation was not attempted during deployment of either device.Upon case completion, the fsa observed that the primary deployment line handle of the first ctagac was missing the connector that joins the deployment line to the handle.Ultimately, the type 1a endoleak was resolved and 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22957394
• Report Number: 2017233-2025-06564
• Device Sequence Number: 18207814
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: (01)00733132646852(17)271201
• Combination Product (Y/N): N
• Initial Reporter State: OH
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 10/03/2025

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 Catalogue Number: TGMR404020
• 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: 08/22/2025
• Supplement Date Received by Manufacturer: 10/03/2025
• Initial Report FDA Received Date: 09/03/2025
• Supplement Report FDA Received Date: 10/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/02/2024
• 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: 80 YR
• Patient Sex: Unknown