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

Catalog Number	TSB121706A
Medical Device Problem Code	Material Separation (1562)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
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.H6: code c21 - results pending determination and completion of investigations.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) 2026, the patient underwent thoracic endovascular aortic repair (tevar) for the treatment of an aortic dissection involving zone 1 (left common carotid artery) using gore® tag® thoracic branch endoprosthesis devices.It was reported that, upon removal of a gore® tag® thoracic branch endoprosthesis (tbe) side branch (sb) component delivery catheter, the leading olive of the delivery catheter separated from the main catheter shaft.It was further reported that the anatomy was not significantly tortuous, with only minor narrowing of the aortic arch.The user reported no excessive force, twisting, or difficult manipulation during device use, and stated that the procedure was otherwise straightforward.Following identification of the separation, an initial attempt to retrieve the separated component using a snare was unsuccessful.The device fragment was subsequently retrieved via arm access using a long catheter to advance the separated component out through the 20 fr sheath.There were no reported patient complications or adverse clinical outcomes associated with this event, and the patient remained stable.

• 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: 25415178
• Report Number: 2017233-2026-07609
• Device Sequence Number: 12222338
• Product Code: MIH
• UDI-Device Identifier: 00733132654413
• UDI-Public: (01)00733132654413(17)290330
• Combination Product (Y/N): Y
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P210032
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• 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): 06/30/2026

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: TSB121706A
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/03/2026
• Supplement Date Received by Manufacturer: 06/29/2026
• Initial Report FDA Received Date: 06/05/2026
• Supplement Report FDA Received Date: 06/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 04/01/2026
• 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
• Patient Age: 60 YR
• Patient Sex: Male