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

Catalog Number	TAC083415A
Medical Device Problem Code	No Apparent Adverse Event (3189)
Health Effect - Clinical Code	Stroke/CVA (1770)
Date of Event	02/15/2025
Type of Reportable Event	Serious Injury
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® excluder® aaa endoprosthesis instructions for use, complications associated with the use of the gore® excluder® aaa endoprosthesis that may occur and/or require intervention include, but are not limited to, stroke.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 borderline mycotic thoracic aneurysm located at the distal edge of lsca using a gore® tag® thoracic branch endoprosthesis (tbe) and gore® tag® conformable thoracic stent graft with active control (ctag).The tbe system was deployed successfully.The portal was ballooned, but the main graft was not.The completion angiograph showed no endoleaks.On (b)(6) 2025, the follow-up ct showed an endoleak - it was unknown whether it was type i or type iii.The physician reintervened february 13th to try ballooning the graft to resolve the endoleak, but that was not successful.On friday, (b)(6) 2025 the physician reintervened again.First, the physician used a coda balloon proximal to the graft.This seemed to resolve the leak, but when the balloon was removed an endoleak could still be seen in steep rao projection.The physician then decided to try to rule out a type iii endoleak using a ctag and a 10x10 viabahn periscope from the portal into the distal graft, but the completion angio still showed a leak.Finally, the physician tried ballooning in the portal while also ballooning the ctag aggressively with a gore® tri-lobe balloon catheter at the portal.This resolved the endoleak.Reportedly, the patient suffered a stroke later that weekend.Patient current status is unknown.

• 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: 21589149
• Report Number: 2017233-2025-05930
• Device Sequence Number: 20920280
• Product Code: MIH
• UDI-Device Identifier: 00733132654093
• UDI-Public: (01)00733132654093(17)270917
• Combination Product (Y/N): N
• Initial Reporter State: DE
• 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
• Report Date (Section B): 03/12/2025

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 Catalogue Number: TAC083415A
• 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: 02/15/2025
• Initial Report FDA Received Date: 03/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 76 YR
• Patient Sex: Female