MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	TGMR403415
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/24/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The following was sent to gore: on (b)(6) 2025, patient underwent an thoracic endovascular aortic repair (tevar) procedure to treat a penetrating atherosclerotic ulcer utilizing a gore® tag® conformable thoracic stent graft with active control system.Reportedly, during the procedure, a tapered ctag nose cone broke off inside the patient's body and the graft landed 4cm distal to left subclavian artery and then distally extended with another ctag.Patient had a previous medtronic graft in the infrarenal that had slipped down with very tortuous anatomy and calcified iliac artery.The ctag tracked fine and deployed fine.Once the catheter was brought out, it was noted that the nose cone was missing of the delivery catheter and upon checking, it was sitting just off the infrarenal on the guidewire.Physician put a lunderquist with snare over it and track where it would open up above it, but the snare would not go past due to tortuosity of the infranrenal aorta, so a 2nd guidewire was put up and snare catheter through and the nose cone would then move over the lunderquist with snare thru the ctag that they deployed and snared the top of the lunderquist wire and pull it out thru the sheath and finished with the distal ctag placement.Overall, deployment was fine with no nose cone resistance felt when withdrawing the catheter, unsure why the nose cone separated.There was no injury to the patient an procedure ended successfully.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.H6: there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device." imaging evaluation summary: two time-points available for evaluation: pre-implantation abd/pelvis cta dated on (b)(6) 2025 and pre-implantation chest cta dated on (b)(6) 2025.Abdomen pelvis cta dated on (b)(6) 2025 shows a medtronic device is implanted in the abdominal aorta.Chest cta dated on (b)(6) 2025 shows: pre-implantation images.Complaint allegedly happened during the on (b)(6) 2025 thoracic endovascular aortic repair.Images provided do not allow for evaluation in relation to the reported complaint.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 have not 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.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h3 and h6.Engineering evaluation summary: the device evaluation found the following: the olive was separated from the leading end of the delivery catheter.The braided shaft at the leading end of the catheter showed damage consistent with a tensile failure of a properly bonded olive and catheter, including damaged braided shaft layers and missing outer layer material.These observations are consistent with the reported event description that the curved leading olive was separated from the catheter.The root cause of the separation of the curved olive from the catheter could not be determined based on the returned device and reported information.No manufacturing deficiency was identified.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23794393
• Report Number: 2017233-2025-06942
• Device Sequence Number: 14845463
• Product Code: MIH
• UDI-Device Identifier: 00733132661695
• UDI-Public: (01)00733132661695(17)271201
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• 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,Followup
• Report Date (Section B): 02/04/2026

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: TGMR403415
• 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: 11/24/2025
• Supplement Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 12/12/2025
• Supplement Report FDA Received Date: 02/04/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 12/02/2024
• 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
• Patient Sex: Male