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

Catalog Number	TSB080806A
Medical Device Problem Code	Material Integrity Problem (2978)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	07/31/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Cbas® heparin surface incorporates cbas-heparin manufactured from heparin sodium api, which is covalently bound to the device surface and is essentially non-eluting.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) 2025, during an endovascular procedure it was reported that post deployment of the gore® tag® thoracic branch endoprosthesis (side branch component tsb).When trying to withdraw the delivery catheter, the nose cone came off.The physician snared the nose cone and in the process of removing the artifact from the patient, the gore® tag® thoracic branch endoprosthesis (tbe) was pulled back and seal was lost and a gore® tag® thoracic branch aortic extender was implanted.The patient tolerated the procedure.
Additional Manufacturer Narrative
The device evaluation showed the catheter separated at the distal shaft and irregularities were present on the distal shaft and olive.The findings of the evaluation are consistent with the reported event description, which stated that ¿the nose cone came off¿.The event description for ¿the tbe graft pulled back when attempting to remove¿ could not be confirmed.The root cause for the leading end of the catheter breaking was likely associated with torquing of the catheter.A manufacturing deficiency associated with the tbe side branch was not identified during the device evaluation.Therefore, per no capa request is required.Events will continue to be monitored by gore.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22866197
• Report Number: 2017233-2025-06522
• Device Sequence Number: 21146785
• Product Code: MIH
• UDI-Device Identifier: 00733132654352
• UDI-Public: (01)00733132654352(17)251025
• Combination Product (Y/N): Y
• Initial Reporter State: OH
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 09/08/2025

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 Expiration Date: 10/25/2025
• Device Catalogue Number: TSB080806A
• 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: 07/31/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 08/21/2025
• Supplement Report FDA Received Date: 09/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/27/2022
• 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
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 86 KG