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	TGMR373720
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c21: a review of the manufacturing records for the devices are going to be conducted.The investigation is in process.The devices remain implanted and are not available for investigation.Also was implanted: tgmr373720/ (b)(6) udi# (b)(4).It is unknown which ctag device was placed proximally during the initial procedure.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
On an unknown date in (b)(6) 2024, a patient was seen for a tevar procedure using a gore® tag® conformable thoracic stent graft with active control (ctag).On an unknown date in (b)(6) 2025, a ct scan showed contrast in the aneurysm sac.The endoleak was not confirmed, but the physician suspected a proximal type i endoleak.On (b)(6) 2025, a reintervention occurred.No contrast was seen on the angio prior to the device being placed.The physician implanted a ctag device proximally, extending to the left subclavian.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for investigation.Also was implanted: tgmr373720/ 28977960 udi# (b)(4) it is unknown which ctag device was placed proximally during the initial procedure.Additional information was requested, however, was not available.According to the conformable gore® tag®thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and reintervention.
Additional Manufacturer Narrative
B5: the event description was updated.H.6.Code c19: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for investigation.Also was implanted: tgmr373720/ (b)(6), udi# (b)(4).It is unknown which ctag device was placed proximally during the initial procedure.The cause of the suspected proximal type i endoleak remains unknown.According to the conformable gore® tag®thoracic endoprosthesis instructions for use (ifu), complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to endoleak and reintervention.
Event or Problem Description
The physician confirmed that on an unknown date in (b)(6) 2025, a proximal type i endoleak was suspected.No aneurysm enlargement was noticed.There was nothing in patient's anatomy caused or contributed to the event.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21972676
• Report Number: 2017233-2025-06145
• Device Sequence Number: 21005511
• Product Code: MIH
• UDI-Device Identifier: 00733132646821
• UDI-Public: (01)00733132646821(17)261103
• Combination Product (Y/N): N
• Initial Reporter State: OR
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/21/2025

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: TGMR373720
• 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: 04/29/2025
• Supplement Date Received by Manufacturer: 05/09/2025; 05/21/2025
• Initial Report FDA Received Date: 05/06/2025
• Supplement Report FDA Received Date: 05/15/2025; 05/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention; Other
• Patient Age: 78 YR
• Patient Sex: Female