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

Catalog Number	TAC124515A
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	05/07/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19 ¿ a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications h6: code b15 ¿ imaging evaluation summary: a clinical imaging specialist reviewed a single post-implantation cta (b)(6) 2026), which shows a dissection extending from the sinotubular junction (stj) to the proximal end of the implanted device.The timing of when the dissection occurred cannot be determined from the available imaging.H6: code b20 ¿ 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 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, the patient underwent a reintervention for treatment of a penetrating aortic ulcer (pau) following prior tevar, with a zone 0 (brachiocephalic artery [bca]/ascending aorta) repair utilizing a gore® tag® thoracic branch endoprosthesis.At the six-month follow-up, computed tomography (ct) imaging demonstrated no abnormalities.On (b)(6) 2026, a one-year follow-up ct scan identified a retrograde type a aortic dissection originating at the sinotubular junction (stj).The finding was subsequently reported to gore on (b)(6) 2026.The exact onset date of the dissection is unknown.The reporter indicated that the event occurred at an indeterminate time between the six-month and one-year follow-up intervals.At the time of reporting, the patient was described as clinically stable.No definitive cause for the dissection has been established.The treating physician is currently evaluating treatment options.Potential management may include open surgical repair; however, no intervention had been scheduled at the time of reporting.

• 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: brittany pettengill ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25285828
• Report Number: 2017233-2026-07551
• Device Sequence Number: 9677941
• Product Code: MIH
• UDI-Device Identifier: 00733132654253
• UDI-Public: (01)00733132654253(17)270810
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/26/2026

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: TAC124515A
• 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
• Initial Report FDA Received Date: 05/26/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Age: 86 YR
• Patient Sex: Female
• Patient Weight: 92 KG