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

Catalog Number	RLT281412
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/16/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
The field sales associate (fsa) reported the following to gore: on (b)(6) 2022, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® excluder® aaa endoprosthesis.The patient tolerated the procedure.On (b)(6) 2025, the patient underwent an endovascular procedure to treat a dissection utilizing the gore® tag® conformable thoracic stent graft with active control system (ctag) in zone 2.The gore® excluder® aaa endoprosthesis was also implanted.It was reported that there was a type 1a endoleak and a type 2 endoleak.An aortic extender was placed on the trunk ipsilateral component to resolve the type 1a endoleak.No treatment was required for the type 2 endoleak.The ctag was used to treat a separate dissection unrelated to the endoleak treatment area.This did not cause the reintervention; however, the physician decided to treat both conditions during the same procedure.The patient tolerated the procedure.It is unknown what caused the reported event to occur.
Additional Manufacturer Narrative
According to the gore® excluder® aaa endoprosthesis instructions for use, adverse events that may occur and / or require intervention include endoleaks.The imaging evaluation determined the following: a one time point available for evaluation: post-implantation cta dated on (b)(6) 2025.A lateral 3d image shows 2 penetrating aortic ulcer¿s (pau¿s) in the descending thoracic aorta (dta).The length from the right renal artery (rra) to the proximal circumferential device appears to be 17.9mm, by outer curve length.Aortic diameters within the 15mm of abdominal aorta distal to the lowest renal artery (rra) appear to range from 25.7mm ¿ 28.8mm.Maximum abdominal aortic aneurysm diameter on (b)(6) 2025 appears to be 67.2mm x 70.5mm.Cannot confirm aneurysm growth or disease progression with one time-point.Comparison series (arterial and delayed contrast) axial images show: there is contrast pooling in the anterior aneurysm sac on both series.The anterior pooling contrast has increased in size and concentration on the delayed contrast image, thereby, suggesting a type ii endoleak.Contrast is also pooling in the posterior sac on both series imaging.Contrast is visualized in a set of lumbar arteries near the pooling contrast in the posterior aneurysm sac on both series images.Cannot confirm ante grade or retrograde flow in the lumbar arteries.Contrast pooling in the posterior aneurysm sac does not appear to be measurably different on the different series images.With available imaging, cannot confirm or rule out if there is a type i 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 have not 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.Correction b3, b5.
Event or Problem Description
On (b)(6) 2025, the patient underwent an endovascular procedure to treat a dissection utilizing the gore® tag® conformable thoracic stent graft with active control system (ctag) in zone 2.The gore® excluder® aaa endoprosthesis was also implanted.

• Brand Name: GORE® EXCLUDER® 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22168058
• Report Number: 3007284313-2025-04019
• Device Sequence Number: 15832776
• Product Code: MIH
• UDI-Device Identifier: 00733132622528
• UDI-Public: (01)00733132622528(17)240413
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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 Expiration Date: 04/13/2024
• Device Catalogue Number: RLT281412
• 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: 05/15/2025
• Supplement Date Received by Manufacturer: 07/23/2025
• Initial Report FDA Received Date: 06/09/2025
• Supplement Report FDA Received Date: 07/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/15/2021
• 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: 87 YR
• Patient Sex: Unknown