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	TGMR404015
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Endoleak (4074)
Health Effect - Clinical Codes	Vascular Dissection (3160); Clinical Endoleak (4843)
Date of Event	06/20/2025
Type of Reportable Event	Death
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® excluder® thoracoabdominal branch endoprosthesis (tambe) and the gore® tag® conformable thoracic stent graft with active control system (ctag) in zone 6.It was reported that all tambe and ctag devices were implanted prior to the patient having cardiac arrest.The physician then attempted to advance a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) through the left subclavian artery (lsa) when the patient coded.The physician and fsa determined that the patient may have had a dissection in the mid descending aorta.The physician stated that the dissection was proximal to the ctag but could not visually see far enough down the proximal descending aorta to make a determination as to exact location of retrograde tear.At this time, the cardiac team was activated, cardiopulmonary resuscitation (cpr) was initiated and the patient was placed on bypass.The physician performed an open thoracotomy with two arch anastomoses.Once the patient came off bypass, they expired.At the time of the cardiac arrest and suspected dissection, the vbx device was being routed to its intended location and had not yet been deployed.The fsa stated the vbx, tambe, and ctag did not cause or contribute to the patient death.The patient ultimately expired after multiple unsuccessful attempts to wean from bypass support.
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.
Additional Manufacturer Narrative
According to the gore® tag® conformable thoracic stent graft with active control system instructions for use, adverse events that may occur and / or require intervention include dissection.As it is unknown which device(s) is directly implicated in this endoleak event, the following device(s) will also be included in this report: catalog #tgmr404010 / serial #(b)(6) / udi #(b)(4).Catalog #tgm342815 / serial #(b)(6) / udi #(b)(4).Added g3/g4, h1/h2, h6: investigation finding and investigation conclusion code.Corrected h6: heath effect clinical and medical device problem code.

• 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: 22541066
• Report Number: 2017233-2025-06427
• Device Sequence Number: 15211123
• Product Code: MIH
• UDI-Device Identifier: 00733132646845
• UDI-Public: (01)00733132646845(17)280320
• Combination Product (Y/N): N
• Initial Reporter State: MI
• 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): 08/05/2025

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: TGMR404015
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 08/05/2025
• Initial Report FDA Received Date: 07/18/2025
• Supplement Report FDA Received Date: 08/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2025
• 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
• Patient Sex: Unknown