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

Catalog Number	CXT231412
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	12/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: imaging evaluation: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ thirteen different radiographic jpeg images provided for evaluation.¿ no name, date, or demographics on the images.¿ cannot manipulate the images in any way.(window leveling, rotating, etc.) ¿ cannot provide diameter or length measurements with jpeg images.¿ all annotations on the jpeg images were completed before submission to gore.¿ cannot confirm annotated diameter measurements without dicom imaging.¿ cannot confirm aneurysm enlargement with images provided for evaluation.¿ case report #1 images contain annotated diameters and lengths that cannot be confirmed with available imaging.¿ case report #2 sagittal reconstruction and axial images appear to show contrast in lumbar arteries at 2 different locations.The first location appears to show contrast in the lumbar artery communicates with contrast pooling in the aneurysm sac.This finding, thereby supports a type ii endoleak at that location.¿ the second set of images shows contrast in a set of lumbar arteries more distally.This set fails to show communication between the contrast in the lumbars and contrast in the sac.Need axial dicom image series (non-contrast, arterial, and delayed contrast image sets) to confirm the type of endoleak on this set of jpeg images.¿ partial reconstructed 3d images are of poor quality.Again, cannot confirm location on a sagittal reconstruction image and a partial 3d is the same location.Cannot confirm a distal type i endoleak with the images provided for evaluation.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 information was reported to gore: on (b)(6) 2024, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® conformable aaa endoprosthesis and gore® excluder® aaa endoprosthesis.On (b)(6) 2025, a contrast-enhanced ct scan showed aneurysm enlargement and suspected type ii and type ib endoleaks; therefore, an additional procedure was indicated.On (b)(6) 2026, a reintervention was performed.An angiography showed a type ii endoleak originating from the iliolumbar artery and a type ib endoleak on the left side.Bilateral iliolumbar artery embolization was performed, and an additional contralateral leg was placed on the left side.The endoleaks disappeared.The patient tolerated the procedure.

• 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: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24206871
• Report Number: 3007284313-2026-04539
• Device Sequence Number: 12152061
• Product Code: MIH
• UDI-Device Identifier: 00733132651016
• UDI-Public: (01)00733132651016(17)261023
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/29/2026

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: CXT231412
• 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: 01/06/2026
• Initial Report FDA Received Date: 01/29/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/25/2023
• 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: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male