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

Catalog Number	TAC083415A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	02/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
It should be noted that, per the gore® tag® thoracic branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to endoleak and aortic expansion.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, the patient underwent an endovascular procedure to treat a dissection utilizing the gore® tag® thoracic branch endoprostheses (tbe) (aortic component and side branch) in zone 2.The patient tolerated the procedure.On (b)(6), cta scans were taken and it was noted that a possible endoleak occurred.The physician was not sure which type of endoleak occurred.On (b)(6) 2025, the patient underwent a reintervention procedure to treat the possible endoleak utilizing the gore® tag® thoracic branch endoprosthesis (side branch) in zone 3.It was reported that the portal was realigned with a new side branch and then ballooned.There were no allegations against the aortic component at this time.The patient tolerated the procedure.The physician does not know what caused the issue to occur but believes it may be an issue with the graft (possible iiib endoleak).On (b)(6) 2025, a cta scan was taken which showed the leak persisted.Also, the false lumen had grown 5mm.On an unknown date, it was determined that it was not the side branch, but it was the aortic component, that contributed to the reported event persisting.On (b)(6) 2025, the patient underwent a reintervention procedure to treat the endoleak utilizing the gore® tag® conformable thoracic stent graft with active control system (ctag) in zone 2.The physician placed the ctag at the proximal portion of the tbe and extended the portal with a 9mm viabahn.The presumed type iiib endoleak was fixed.The endoleak could not be located angiographically.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6: code b15 - images were provided, and an imaging evaluation was performed.An analysis of relevant data will be performed in view of supporting the identification of possible causes of the event.The device imaging evaluation showed the following: three time-points and one radiographic jpeg image available for evaluation: post-implantation cta¿s dated (b)(6) 2025.An endoleak cannot confirm an with the jpeg image provided.Post-implantation cta imaging of (b)(6) 2025 shows: comparison series imaging (non-contrast, arterial contrast and delayed contrast).There appears to be contrast in the aneurysm sac on the arterial contrast series image.The pooling contrast appears to increase on the delayed contrast series image.Thereby, suggesting a type ii endoleak.Contrast is seen in an intercostal artery communicating with the sac at the level of the implanted device and pooling contrast.There appears to be an aortic tear or fenestrations at the distal end of the implanted device.Contrast is visualized in the false lumen.There appears to be a similar amount of contrast in the false lumen on the arterial and delayed contrast series images.Post-implantation cta images dated (b)(6) 2025 comparison series imaging shows: pooling contrast in the sac is again visualized on this time-point.The amount of pooling contrast has increased on the delayed contrast image.Thereby, confirming a type ii endoleak.Intercostal artery visualized on an arterial contrast image communicating with the sac at the level of the implanted device.There appears to be a tear or fenestrations at the distal end of the implanted device.Contrast is seen in the false lumen.Post-implantation cta images dated (b)(6) 2025 shows: comparison series imaging (non-contrast, arterial contrast and delayed contrast) shows: additional side branch device(s) on this time-point.There is contrast pooling in the sac on the delayed contrast image.There is an additional aortic device on this time-point extending distally from the original gore® tag® thoracic branch endoprosthesis in the dta.There still appears to be false lumen that is being perfused.There appears to be contrast in the false lumen on all the series images including the non-contrast image at this level on the (b)(6) 2025 time point.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21518619
• Report Number: 2017233-2025-05887
• Device Sequence Number: 9695703
• Product Code: MIH
• UDI-Device Identifier: 00733132654093
• UDI-Public: (01)00733132654093(17)270917
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 04/17/2025

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: TAC083415A
• 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: 02/07/2025
• Supplement Date Received by Manufacturer: 04/01/2025
• Initial Report FDA Received Date: 03/04/2025
• Supplement Report FDA Received Date: 04/17/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 09/18/2024
• 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
• Patient Age: 59 YR
• Patient Sex: Male