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

Catalog Number	TAC083715A
Medical Device Problem Code	Activation Failure (3270)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/16/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b21 and c21 - investigation and results pending expected device return and engineering analysis.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.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) 2026, the patient underwent an endovascular procedure to treat a penetrating aortic ulcer (pau) just distal to the left subclavian artery (lsa) utilizing a gore® tag® thoracic branch endoprosthesis (tac083715a).Reportedly, the device was inserted into the patient, advanced to the target location, and upon pulling the deployment knob, the device did not deploy.The deployment line would not release the constrained device.The cause of the deployment issue is unknown.The device was removed from the patient and another gore® tag® thoracic branch endoprosthesis was implanted successfully.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added d9 (date device returned to manufacturer), g3/g4, h1/h2/h3, h6.Device evaluation: removed b21 type of investigation not yet determined, c21 results pending completion of investigation, and d16 conclusion not yet available.Added b01 testing of actual/suspected device, c1601 assembly problem identified, and d0301 manufacturing deficiency.Gore device evaluation: the gore® tag® thoracic branch endoprosthesis (tbe) aortic component (ac) device evaluation for (b)(4) showed the following: the device evaluation showed the ac device was undeployed and appeared bowed.Additionally, the deployment knob was detached from the deployment lines and not returned.The deployment lines were pulled to attempt deployment of the device.The short sleeve deployed fully; however, the long sleeve and torque sleeve were not deployed.The findings of the evaluation are consistent with the reported event description, which stated that ¿the deployment line would not release the constrained device¿ as the device did not fully deploy.Per the manufacturing product history review (phr), (b)(4), a review of the manufacturing records indicated that the manufacturing lot met all pre-release specifications.The observation of inability to fully deploy the tbe ac device during the device evaluation was due to an incorrect knot on the proximal end of the long sleeve of the device.This incorrect knot prevented the long sleeve deployment stitches from unlacing and likely caused the observed bowed state of the device.Due to the presence of an incorrect knot preventing device deployment identified during the device evaluation, it is likely the failure mode is attributable to the manufacturing process.

• 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: brianna zipprich ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24257508
• Report Number: 2017233-2026-07108
• Device Sequence Number: 8327191
• Product Code: MIH
• UDI-Device Identifier: 00733132654116
• UDI-Public: (01)00733132654116(17)280330
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/18/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Catalogue Number: TAC083715A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/16/2026
• Supplement Date Received by Manufacturer: 02/18/2026
• Initial Report FDA Received Date: 02/04/2026
• Supplement Report FDA Received Date: 02/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2025
• 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: Other
• Patient Age: 74 YR
• Patient Sex: Male