MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC BRAND NAME PRODUCT CODE STENT GRAFT WITH ACTIVE; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Model Number	TGM454510
Medical Device Problem Codes	Insufficient Device Problem Information (3190); Appropriate Device Problem Term/Code Not Available (3191); Patient Device Interaction Problem (4001)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	07/01/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information will be provided.The device remains implanted and is not available for analysis.Code f28 was used to cover that the physician is monitoring the patient and will plan to do the reintervention.Code a26 was used to cover that the cause of aneurysm enlargement remains unknown.Code a27 was used to cover that the physician is going to do the reintervention to fix the disease progression.The information was requested from the site and will be provided.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 (b)(6) 2022, the patient underwent treatment of a thoracic aortic aneurysm proximal to the brachiocephalic trunk, distal to the sino tubular junction (zone 0) with conformable gore® tag® thoracic endoprostheses and gore® tag® thoracic branch endoprostheses.The patient tolerated the procedure.Pre- treatment maximum thoracic aortic aneurysm diameter was 61.4mm.From (b)(6) 2022 to (b)(6) 2025, the maximum aortic diameter increased in size from 65mm to 72.3mm.According to the site, the patient has distal aneurysmal disease (type iv)- distal thoracic aorta and visceral segment aneurysm.The event is ongoing.According to the site, this problem is unrelated to the device or procedure.The patient is going to be treated for type iv segment on (b)(6) 2025.
Additional Manufacturer Narrative
During the data review, it was found that the incorrect device was added to investigation.The correct device is: tgm454510/(b)(6).The section d: suspect medical device was updated.H.6.Code c21: a review of the manufacturing records for the device is going to be conducted.The investigation is in process.Further information physician will is be provided.The device remains implanted and is not available for analysis.
Additional Manufacturer Narrative
B5: the event description was updated.H.6.Code c19: a review of the manufacturing records indicated the lot met all pre-release specifications.The device remains implanted and is not available for analysis.Code f28 was used to cover that the physician is monitoring the patient and will plan to do the reintervention.Code a27 was used to cover that the physician is going to do the reintervention to fix the disease progression.It was reported that the aortic aneurysm enlargement was below the distal ctag and looks like a disease progression.According to the site, this problem is unrelated to the device or procedure.
Event or Problem Description
On (b)(6) 2022, the patient underwent treatment of a thoracic aortic aneurysm proximal to the brachiocephalic trunk, distal to the sino tubular junction (zone 0) with conformable gore® tag® thoracic endoprosthesis devices (ctag) and gore® tag® thoracic branch endoprosthesis devices (tbe).The patient tolerated the procedure.Pre- treatment maximum thoracic aortic aneurysm diameter was 61.4mm.From (b)(6) 2022 to (b)(6) 2025, the maximum aortic diameter increased in size from 65mm to 72.3mm.According to the gore study manager, after the ct scan review, the aortic aneurysm enlargement was below the distal ctag and looks like a disease progression.According to the site, the patient has distal aneurysmal disease (type iv)- distal thoracic aorta and visceral segment aneurysm.The event is ongoing.According to the site, this problem is unrelated to the device or procedure.The patient is going to be treated for type iv segment on (b)(6) 2025.This upcoming tambe procedure scheduled for the subject does not involve any of the devices implanted for the tbe procedure.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC BRAND NAME PRODUCT CODE STENT GRAFT WITH ACTIVE
• 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: 22172758
• Report Number: 2017233-2025-06288
• Device Sequence Number: 21136867
• Product Code: MIH
• UDI-Device Identifier: 00733132646982
• UDI-Public: (01)00733132646982(17)220612
• Combination Product (Y/N): N
• Initial Reporter State: WI
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/10/2025

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: 06/12/2022
• Device Model Number: TGM454510
• Device Catalogue Number: TGM454520
• 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: 06/04/2025
• Supplement Date Received by Manufacturer: 06/23/2025; 07/09/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 06/26/2025; 07/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/28/2022
• 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: Required Intervention; Other; Hospitalization
• Patient Age: 69 YR
• Patient Sex: Female
• Patient Weight: 104 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White