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	TGMR313120
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	10/10/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Patient medications: tylenol, oxycodone, tramadol, bupropion, and hydrochlorothiazide 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 reported the following: on (b)(6) 2025, the patient was implanted with gore® tag® conformable thoracic stent graft with active control system to treat a thoracic aneurysm.Reportedly the patient had a previous abdominal aortic aneurysm that was treated with several medtronic aorto-uni-iliac devices.There was no right sided access due to a previous fem-fem bypass procedure.The physician performed a left side retroperitoneal cutdown for access.Access was pre-dilated with a 16fr and a 18fr dilator before advancing a 20fr sheath for the procedure.It was reported that there was mild resistance while advancing the delivery catheter of the gore® tag® conformable thoracic stent graft with active control system.After the primary deployment was performed, the physician noticed that 2cm distal of the proximal end of the graft was compressed.Full deployment was completed, and the compression remained.During the final stage of deployment, the graft in-folded on itself (1800-e:-implantable device events post deployment - other/unknown).The physician removed the delivery catheter and ballooned the graft and then relined with two additional gore® tag® conformable thoracic stent graft with active control system devices.The patient tolerated the procedure.Reportedly, the physician while reviewing the images of the procedure, it was noticed that a 2cm in length graft (not a gore device) from a previous surgery had been dislodged when advancing the sheath.This graft was the cause of the compression.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23420503
• Report Number: 2017233-2025-06760
• Device Sequence Number: 20903200
• Product Code: MIH
• UDI-Device Identifier: 00733132646791
• UDI-Public: (01)00733132646791(17)280227
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• 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
• Report Date (Section B): 10/29/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TGMR313120
• 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: 10/10/2025
• Initial Report FDA Received Date: 10/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 81 YR
• Patient Sex: Female
• Patient Weight: 52 KG