MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® EXCLUDER® CONFORMABLE AAA ENDOPROSTHESIS; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number	CXA280005
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	04/08/2026
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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
The following was reported: on (b)(6) 2026, the patient underwent endovascular treatment of a dissection at the abdominal aorta using a gore® excluder® thoracoabdominal branch endoprosthesis (tambe) device system.Reportedly, during the procedure, between stenting the right and left renal arteries, the patient developed a dissection throughout the thoracic aorta.The celiac, sma, and right renal arteries were all successfully stented prior to this.The physicians elected to plug the left renal portal as the left renal artery was no longer filling.An aortic extender was used to extend the tambe device distally and seal in the prior surgical graft.The procedure was aborted, and the patient was taken for a stat ct scan.This showed a dissection from the level of the left subclavian artery extending through the tambe treatment zone.The tambe device was also compressed from the false lumen.It was reported that the physicians felt this was likely due to trauma from the axillary sheath, which was a dsf1233.The patient was taken back to the or for open surgical repair.The patient responded well to the frozen elephant trunk (fet) open conversion.The true lumen opened up and distal pulses improved.The chest was left open.There was bleeding in the chest and the patient was brought back the following morning for washout.Patient was then brought back for closure.A follow-up cta showed the false lumen between the fet and tambe device filling and carrying down into the aneurysm sac.On (b)(6) 2026, the physician performed a left carotid to left subclavian bypass as the left subclavian artery was not bypassed during the open conversion.On (b)(6), 2026, the patient was brought back for ctag placement to bridge the fet and tambe devices.This was using a tgm343420, serial: (b)(6).The procedure was well tolerated and without complication.At the end of the case the left subclavian origin was embolized to prevent retrograde fill of the thoracic aorta.

• Brand Name: GORE® EXCLUDER® CONFORMABLE AAA 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25061622
• Report Number: 3007284313-2026-04755
• Device Sequence Number: 13099772
• Product Code: MIH
• UDI-Device Identifier: 00733132650958
• UDI-Public: (01)00733132650958(17)280811
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• 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: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 06/05/2026

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: CXA280005
• 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: 04/08/2026
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 05/01/2026
• Supplement Report FDA Received Date: 05/20/2026; 06/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/13/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization
• Patient Age: 56 YR
• Patient Sex: Female
• Patient Weight: 45 KG