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	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Unspecified Kidney or Urinary Problem (4503)
Date of Event	03/05/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Investigation conclusions code d16: investigation conclusions waiting more information from site.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.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 from the aaa 24-01 tambe post approval study and information was obtained from the imedidata clinical database: on (b)(6) 2026, a patient was treated using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe).On (b)(6) 2026, the patient was listed as having an acute kidney injury.The event is listed as procedure related, and the event is ongoing, but no treatment is listed.On (b)(6) 2026, the patient was discharged home.The renal arteries were patent prior to the procedure.It is unknown if any devices were placed in the renal arteries.On the risk assessment form, prior to procedure renal status is given a score of 2, indicating patient creatinine levels are elevated, between 2.5 and 5.9 mg/dl.At discharge, 5 days post-op the creatinine level was 1.25 mg/dl.
Event or Problem Description
The following was reported from the aaa 24-01 tambe post approval study and information was obtained from the imedidata clinical database: on (b)(6) 2026, a patient was treated using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) system, including gore® viabahn® vbx balloon expandable endoprosthesis devices in the renal arteries.Device placement was successful, and imaging on march 4 showed patent renal arteries.The event is listed as procedure related and ongoing.On (b)(6)2025, a risk assessment was taken, showing where renal status was given a score of 2, indicating patient creatinine levels were elevated, between 2.5 and 5.9 mg/dl.However, prior to the operation, creatinine levels had dropped to 1.09 mg/dl.On (b)(6) 2026, creatinine levels increased to 1.33 mg/dl, and the patient was listed as having an acute kidney injury.This was expected to resolve on its own, so no treatment was given.The event was listed as procedure related.On (b)(6) 2026, the patient was discharged home.The creatinine level was 1.25 mg/dl.On (b)(6) 2026, the patient was seen for a follow-up appointment.At that time, creatinine level was 1.7 mg/dl.
Additional Manufacturer Narrative
Added the following: a2; age a3a: sex a4: weight d4: catalog number, expirationdate, serial number, udi number d6a: date implanted updated b4: event description updated h.6.Type of investigation from b21 to b13,b14,b20 updated h.6.Investigation findings from c21 to c19, c20 updated h.6.Investigation conclusions from d16 to d12, d15 h.6.Type of investigation code b20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25018103
• Report Number: 3007284313-2026-04744
• Device Sequence Number: 9506264
• Product Code: QZK
• UDI-Device Identifier: 00733132659678
• UDI-Public: (01)00733132659678(17)280531
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P230023
• 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: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 06/18/2026

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
• 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: 03/31/2026
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 04/28/2026
• Supplement Report FDA Received Date: 06/18/2026
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 77 YR
• Patient Sex: Male
• Patient Weight: 286 LB
• Patient Race: White