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	TGM343420
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Renal Impairment (4499)
Date of Event	05/08/2026
Type of Reportable Event	Death
Additional Manufacturer Narrative
H6: code c21 - results pending completion of product history review.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.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.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
On (b)(6) 2026, the subject was being treated for an unknown etiology, utilizing the investigational gore® ascending stent graft (asg clinical study 2402).A gore® tag® conformable thoracic stent graft with active control was also implanted during the procedure.As per clinical study database, it was reported on the same day of the procedure (b)(6) 2026, the subject experienced an acute kidney injury, treatment including relieving malperfusion surgically.In addition, subject also experienced a hemorrhage episode on (b)(6) 2026, which led to death.It is currently unknown if this death is related to any post-market devices.Further information has been requested.
Additional Manufacturer Narrative
After further information was received from the clinical study team, it was determined this event is a non-reportable event as there is no allegation against the implanted gore® tag® conformable thoracic stent graft with active control.Additional information was provided from the clinical study team.The patient was being treated for an acute dissection, which resulted in kidney injury.The kidney injury resolved after the procedure.The physician also reported the patient death was not attributed to any gore devices implanted.Patient death was caused by an aortic rupture that occurred and is attributed to patient condition.The fda report (2017233-2026-07626) shall be retracted.
Event or Problem Description
Additional information was provided from the clinical study team.The patient was being treated for an acute dissection, which resulted in kidney injury.The kidney injury resolved after the procedure.The physician also reported the patient death was not attributed to any gore devices implanted.Patient death was caused by an aortic rupture that occurred and is attributed to patient condition.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25462009
• Report Number: 2017233-2026-07626
• Device Sequence Number: 21014034
• Product Code: MIH
• UDI-Device Identifier: 00733132646975
• UDI-Public: (01)00733132646975(17)281007
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/23/2026

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: TGM343420
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/23/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 06/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/09/2025
• 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 Sex: Unknown