MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® THORACIC ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGT3720
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/25/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2012, the patient underwent endovascular treatment of a descending aortic aneurysm using two gore® tag® thoracic endoprosthesis devices.Both tag devices were implanted in the descending aorta and the procedure was successfully completed.On (b)(6) 2020, the patient underwent aortic arch replacement and open stent graft placement to treat a preexisting aortic arch aneurysm.On (b)(6) 2025, ct examination confirmed that the distal tag device had migrated to the proximal side, resulting in a distal type i endoleak with aneurysm enlargement.On (b)(6) 2025, a reintervention was performed using gore® tag® conformable thoracic stent graft with active control system (ctagac).The ctagac was deployed in the distal side to treat the distal type i endoleak.During the deployment and balloon molding, the device moved to proximal side, but no endoleak was observed.The distal type i endoleak was resolved, and the procedure was successfully completed.
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
Section h6 codes updated to reflect results of investigation.

• Brand Name: GORE® TAG® THORACIC ENDOPROSTHESIS
• 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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22208667
• Report Number: 2017233-2025-06310
• Device Sequence Number: 8149266
• Product Code: MIH
• UDI-Device Identifier: 00733132613687
• UDI-Public: (01)00733132613687(17)140430
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,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: 04/30/2014
• Device Catalogue Number: TGT3720
• 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: 05/27/2025
• Supplement Date Received by Manufacturer: 05/27/2025
• Initial Report FDA Received Date: 06/15/2025
• Supplement Report FDA Received Date: 09/02/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/10/2011
• 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: 88 YR
• Patient Sex: Male