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 Codes	Malposition of Device (2616); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	02/28/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
According to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), complications associated with use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleaks, aortic expansion (aneurysm), stent graft: migration and reoperation.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated on (b)(6) 2024.There is a non-gore device located in the distal thoracic aortic arch extending into the descending thoracic aorta (dta).Reconstruction image confirms the presence of a gore® tag® conformable thoracic stent graft with active control system in the thoracic aortic arch.The length from the brachocelphic/lcca (bca/lcca) artery to the proximal circumferential gore® tag® conformable thoracic stent graft with active control system appears to be ~7.3cm, by outer curve length.Images show the thoracic aorta diameters within this ~7.2cm, by outer curve length, of aorta in the arch appear, to range from ~28mm ¿ 55.3mm.Images show there is lack of proximal circumferential device apposition of the gore® tag® conformable thoracic stent graft with active control system.The device appears to be ¿bird beeking¿ on the inner curve.Contrast is seen outside the proximal implanted device, thereby confirming a proximal type i endoleak.Proximal landing zone diameters on (b)(6) 2024 appear to range from ~28mm ¿ 31mm.Axial images show the maximum abdominal aorta aneurysm (aaa) diameter on (b)(6) 2024 was ~96mm x 96mm.Cannot confirm aneurysm growth with one time-point.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.
Event or Problem Description
The following was reported to gore: on an unknown date, patient underwent an unknown procedure with a non-gore graft (medtronic).On (b)(6) 2023, the patient underwent an endovascular reintervention procedure on the non-gore graft for aneurysm rupture utilizing a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2025, the patient underwent an endovascular reintervention procedure to treat the previous rupture that due to a bird beak over time had caused a type 1a endoleak, which got large enough (aneurysm size unknown but continued to grow) that the graft pulled away distally (distance unknown) from the proximal landing zone.Patient anatomy was tortuous.Physician did an open surgical debranching procedure then placed a gore® tag® conformable thoracic stent graft with active control system into the ascending aorta covering the entire arch.Patient is doing okay after 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: parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21713593
• Report Number: 2017233-2025-05997
• Device Sequence Number: 10130764
• Product Code: MIH
• UDI-Device Identifier: 00733132646852
• UDI-Public: (01)00733132646852(17)250105
• Combination Product (Y/N): N
• Initial Reporter State: IN
• 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
• Report Date (Section B): 03/27/2025

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: 01/05/2025
• 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: 02/28/2025
• Initial Report FDA Received Date: 03/27/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention; Hospitalization
• Patient Age: 82 YR
• Patient Sex: Female