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

Catalog Number	TSB081706A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/22/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional gore® tag® device captured on this report: sn: (b)(6), udi: (b)(4), catalog: tsb081706a.H.6.Investigation findings code c21: conclusions waiting on results of phr and imaging evaluation.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 following was reported to gore: on (b)(6) 2025, a patient was treated for a zone 2 thoracic aneurysm using the gore® tag® thoracic branch endoprosthesis (tbe) system.The aortic component was successfully deployed.While advancing the side branch, the portal moved posterior.This led to the device losing proximal seal, and the device migrated distally about 6-7cm.The side branch was deployed, but a second side branch was required.Additionally, the tbe was extended proximally with a gore® tag® conformable thoracic stent graft (ctag).On the completion angiogram, a type iii endoleak was noticed between the aortic component and a branch component of the tbe.A reintervention is planned to extend the portal with another side branch component.Reportedly the steep angle of the lsa to the aortic arch likely caused the issue.
Additional Manufacturer Narrative
H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusions code d12: it should be noted that, per the gore® tag® thoracic branch endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic branch endoprosthesis that may occur include, but are not limited to, endoleak.
Additional Manufacturer Narrative
H.6.Type of investigation code b15: post-implantation cta dated on (b)(6) 2025 shows: the proximal gold band of the first implanted gore® tag® thoracic branch endoprosthesis (tbe) appears to be ~6-8cm distal to the proximal landing zone.Axial images show the lsa is patent.However, there does not appear to be any of the tbe side branch extending into the lsa.There appears to be contrast outside the implanted devices.Due to the side branch being disconnected from the lsa, a type iii endoleak is present because of the thoracic component and side branch disconnection and the connection with the vessel is broken.H.6.Investigation conclusions code d12: it should be noted that, per the gore® tag® thoracic branch endoprosthesis instructions for use, complications associated with the use of the gore® tag® thoracic branch endoprosthesis that may occur include but are not limited to endoleak.

• Brand Name: GORE® TAG® THORACIC BRANCH 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21341042
• Report Number: 2017233-2025-05811
• Device Sequence Number: 17106124
• Product Code: MIH
• UDI-Device Identifier: 00733132654390
• UDI-Public: (01)00733132654390(17)260801
• Combination Product (Y/N): Y
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 05/08/2025

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
• Device Expiration Date: 08/01/2026
• Device Catalogue Number: TSB081706A
• 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: 01/22/2025
• Supplement Date Received by Manufacturer: 03/10/2025; Not provided
• Initial Report FDA Received Date: 02/09/2025
• Supplement Report FDA Received Date: 03/10/2025; 05/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/03/2023
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female