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	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Ischemia Stroke (4418)
Date of Event	05/15/2025
Type of Reportable Event	Death
Event or Problem Description
The following was reported to gore: on (b)(6) 2025, patient underwent an endovascular treatment using a gore® excluder® iliac branch endoprosthesis, gore® excluder® aaa endoprosthesis, gore® excluder® thoracoabdominal branch endoprosthesis (tambe) in zone 5 where a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device) devices were used as branch devices in the visceral arteries.It was reported prior to the procedure; the patient's left renal artery was already occluded.During the procedure, there was a distal perforation in the right renal due to a 0.035" rosen guidewire.The perforation was resolved by placement of a non-gore coronary covered stent.The physician had right sided access due to the left subclavian being stenotic and already having an unknown stent in place from a previous surgery.The physician implanted all devices without any issues.Two vbx devices were implanted in the sma, three vbx devices were implanted in the right renal, and two vbx devices were implanted in the celiac.The patient tolerated the procedure.On (b)(6) 2025, it was reported the patient had a stroke and expired.The physician stated displacement of atheroma (plaque) in the arch, moved to the patient's head and legs causing the stroke.
Additional Manufacturer Narrative
According to the gore® excluder® thoracoabdominal branch endoprosthesis instructions for use, adverse events that may occur and / or require intervention include neurologic damage, local or systemic (e.G., stroke) and death.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
Added g3/g4, h1/h2, h6.Corrected b3.

• 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 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: 22175615
• Report Number: 2017233-2025-06291
• Device Sequence Number: 20787996
• Product Code: QZK
• UDI-Device Identifier: 00733132659678
• UDI-Public: (01)00733132659678(17)271215
• Combination Product (Y/N): N
• Initial Reporter State: MO
• 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
• Report Date (Section B): 07/23/2025

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: 05/14/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/10/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 12/16/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Death
• Patient Age: 74 YR
• Patient Sex: Female