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	ATAA43720160A
Medical Device Problem Codes	Obstruction of Flow (2423); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Stenosis (2263); Thrombosis/Thrombus (4440); Reduced Blood Flow (4598)
Date of Event	01/30/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6.Code c19: a review of manufacturing records of the device indicated the lot met pre-release specifications.The device remains implanted and is not available for analysis.Further information was requested and will be provided.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) 2026, the patient underwent endovascular procedure to treat a thoracoabdominal aortic aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.Gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) were implanted with the tambe device.The patient tolerated the procedure.On (b)(6) 2026, it was reported that the renal artery stenosis was noticed 1 day after the implant procedure, and the mesenteric angiogram was performed for concern of thrombosis of renal stents placed during the tambe procedure.Based on the study data, there was no intervention involving the index device (tambe device or any stent or stent graft in contact with any tambe component).The issue was resolved without sequelae on (b)(6) 2026.The physician is monitoring the patient.
Additional Manufacturer Narrative
This report was sent as a retraction.Based on the information provided that there was superior vena cava (svc) thrombus from patient's prior central line, and no gore devices were occluded, and renal and/or mesenteric artery stenosis and the thrombectomy and extension of sma stent procedure were not attributed to the gore® excluder® thoracoabdominal branch endoprosthesis, there is no allegation against this device and this event is not reportable.
Event or Problem Description
This report was sent as a retraction: based on the information provided that there was superior vena cava (svc) thrombus from patient's prior central line, and no gore devices were occluded, and renal and/or mesenteric artery stenosis and the thrombectomy and extension of sma stent procedure were not attributed to the gore® excluder® thoracoabdominal branch endoprosthesis, there is no allegation against this device and the event is not reportable.
Event or Problem Description
On (b)(6) 2026, the patient underwent endovascular procedure to treat a thoracoabdominal aneurysm using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.Gore® viabahn® vbx balloon expandable endoprosthesis (vbx devices) were implanted with the tambe device.The patient tolerated the procedure.Reportedly, there were concerns for possible renal and/or mesenteric artery stenosis due to patient complaining of persistent back pain, nausea, and cramping.On (b)(6) 2026, it was reported that renal artery stenosis was noticed 1 day after the implant procedure, and the mesenteric angiogram was performed for concern of thrombosis of renal stents placed during the tambe procedure.No devices were attributed to thrombosis.Post mesenteric angiogram on (b)(6) 2026, the findings indicated that the bilateral arteries were patent on iv ultrasound, the bilateral renal stents were patent without evidence of kinking on iv ultrasound, and no evidence of dissection in the bilateral renal arteries.Reportedly, the gore devices were not occluded by thrombosis.When discussed with radiology on (b)(6) 2026, per vascular surgery progress note that there was noted svc thrombus, likely from patient's prior central line.On (b)(6) 2026, the patient had a re-intervention procedure which included left femoral cutdown, thrombectomy and extension of sma stent.The patient tolerated the procedure and discharged home with home on (b)(6) 2026.
Additional Manufacturer Narrative
B5: event description was updated.H6.Code c19: a review of manufacturing records of the device indicated the lot met pre-release specifications.The device remains implanted and is not available for analysis.

• 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: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24372687
• Report Number: 3007284313-2026-04576
• Device Sequence Number: 17535811
• Product Code: QZK
• UDI-Device Identifier: 00733132659685
• UDI-Public: (01)00733132659685(17)280727
• Combination Product (Y/N): N
• Initial Reporter State: VA
• 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,Followup
• Report Date (Section B): 03/12/2026

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
• Operator of Device: Health Professional
• Device Catalogue Number: ATAA43720160A
• 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: 02/03/2026
• Supplement Date Received by Manufacturer: 02/25/2026; 03/04/2026
• Initial Report FDA Received Date: 02/17/2026
• Supplement Report FDA Received Date: 03/04/2026; 03/12/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/29/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Female
• Patient Weight: 76 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White