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

Catalog Number	TSB081006A
Medical Device Problem Code	Blocked Connection (2888)
Health Effect - Clinical Code	Thrombosis/Thrombus (4440)
Date of Event	05/27/2025
Type of Reportable Event	Serious Injury
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.The instructions for use (ifu) states, possible adverse events and complications that may occur with the use of gore® tag® thoracic branch endoprosthesis include, but are not limited to: reoperation, branch vessel occlusion or obstruction.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, this patient underwent endovascular treatment for a zone 2 branched endovascular aneurysm repair (bevar) and the patient was implanted with gore® tag® thoracic branch endoprostheses.It was reported that during removal of the 24 fr gore® dryseal introducer sheath the right external iliac artery (reia) was ruptured.The physician advanced a balloon got control and implanted a gore® viabahn expandable endoprosthesis to treat the rupture.It was reported that the patient¿s reia diameter measured approximately 6.8 mm.The patient did not require any transfusion and blood loss was reported to have been minimal (amount unknown).The patient tolerated the procedure with good results.On (b)(6) 2025, the patient underwent reintervention for a suspected kink of the gore® tag® thoracic branch endoprosthesis (side branch component tsb).Computed tomography angiography performed this date showed some narrowing of the left subclavian artery (lsa), and thrombus building on the tsb.The physician performed additional angioplasty at the area of the kink on the tsb device using an 8mm balloon, and then using a 9mm balloon.The physician reported good results and believed to have resolved any kink.The physician believes during the index procedure the area had not been sufficiently ballooned.The patient tolerated the procedure.

• 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: 22145564
• Report Number: 2017233-2025-06274
• Device Sequence Number: 12598401
• Product Code: MIH
• UDI-Device Identifier: 00733132654369
• UDI-Public: (01)00733132654369(17)271211
• Combination Product (Y/N): Y
• Initial Reporter State: MI
• 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
• Report Date (Section B): 06/04/2025

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
• Operator of Device: Health Professional
• Device Catalogue Number: TSB081006A
• 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: 05/27/2025
• Initial Report FDA Received Date: 06/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/12/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention; Other; Hospitalization
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 61 KG