MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS; ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO

Catalog Number	ATAA43120160A
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/20/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Updated section g3/g4, b4, and h1.It was reported that upon scheduled reintervention surgery on (b)(6) 2025, the physician angiographically interrogated the stent branches, especially the left renal branch, and could not produce an endoleak.Physician concluded that the leak evidenced on the previous ct scan, was most likely read incorrectly as a type 3, and is actually a type 2 leak.Physician indicated that he would continue to monitor this patient and the leak diligently.
Event or Problem Description
It was reported that upon scheduled reintervention surgery on (b)(6) 2025, the physician angiographically interrogated the stent branches, especially the left renal branch, and could not produce an endoleak.Physician concluded that the leak evidenced on the previous ct scan, was most likely read incorrectly as a type 3, and is actually a type 2 leak.Physician indicated that he would continue to monitor this patient and the leak diligently.
Additional Manufacturer Narrative
Updated section g3/g4, h6, and h10.The imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2025.Reconstruction images show there is a ~7cm long vbx in the left renal artery (lra) portal and vessel.Comparison image series (arterial contrast and delayed contrast) show: there is contrast outside the left renal artery portal/stent on the arterial contrast image.Contrast is seen outside the implanted devices at the level of the left renal artery.Contrast is seen outside the implanted devices at the level of the left renal artery and anteriorly in the sac.Contrast is pooling in the aneurysm sac but not increased on the delayed contrast series.This finding indicates the endoleak is not a type ii endoleak.(pooling contrast can be increased on the delayed contrast series if it is a type ii endoleak.) axial images show contrast outside the vbx in the lra.Endoleak of unknown type confirmed with available imaging.
Event or Problem Description
The clinical specialist reported the following information: on (b)(6) 2025, the patient underwent endovascular treatment of a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.The procedure was completed with no reported issues, and no endoleaks were observed at the close of the procedure.A bxb057902a gore® viabahn® vbx balloon expandable endoprosthesis (vbx) was implanted in the left renal artery.It was reported on an unknown date, follow-up imaging was performed and a suspected type iii endoleak was observed from the left renal portal.It was suspected that additional ballooning may be required and may be the cause of the endoleak.A reintervention will be performed at a later date.The fsa was notified about this endoleak on 8/20/2025.
Additional Manufacturer Narrative
H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.It should be noted that, per the gore® excluder® thoracoabdominal branch endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.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.
Additional Manufacturer Narrative
Updated section g3/g4, b5, and h10.
Event or Problem Description
It was later reported reintervention will be performed on (b)(6) 2025.

• Brand Name: GORE® EXCLUDER® THORACOABDOMINAL BRANCH ENDOPROSTHESIS
• Common Device Name: ENDOVASCULAR SYSTEM FOR TREATMENT OF THORACOABDOMINAL AND PARARENAL AORTIC LESIO
• Manufacturer (Section D): W. L. GORE & ASSOCIATES, INC.; 1505 n. fourth street; flagstaff AZ 86004
• Manufacturer (Section G): MEDICAL PHOENIX 1 B/P; 32360 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23059726
• Report Number: 3007284313-2025-04251
• Device Sequence Number: 10044980
• Product Code: QZK
• UDI-Device Identifier: 00733132659678
• UDI-Public: (01)00733132659678(17)271015
• Combination Product (Y/N): N
• Initial Reporter Country: US
• PMA/510(K) Number: P230023
• 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,Followup,Followup
• Report Date (Section B): 11/21/2025

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: ATAA43120160A
• 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: 08/20/2025
• Supplement Date Received by Manufacturer: 10/08/2025; 10/20/2025; 11/21/2025
• Initial Report FDA Received Date: 09/15/2025
• Supplement Report FDA Received Date: 10/10/2025; 10/20/2025; 11/21/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/16/2024
• 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: 77 YR
• Patient Sex: Male