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

Catalog Number	RMT261416
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Hemorrhage/Blood Loss/Bleeding (1888); Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/21/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2012, the patient underwent an endovascular procedure to treat an abdominal aortic aneurysm utilizing a gore® excluder® aaa endoprosthesis.On (b)(6) 2025, ct imaging demonstrated an enlarging aneurysm sac measuring approximately 5.3 × 5.9 cm with findings suggestive of a type ii endoleak.On (b)(6) 2026, angiographic evaluation was performed to further assess and potentially treat the suspected type ii endoleak.Selective catheterization and embolization were attempted; however, definitive catheterization was not achieved due to vessel tortuosity.No embolization was performed, and the suspected endoleak persisted.On (b)(6) 2026, ct angiography confirmed a type ii endoleak within the distal aortic sac with aneurysm sac enlargement measuring approximately 6.2 cm.On (b)(6) 2026, the patient underwent an open surgical repair of the abdominal aortic aneurysm with explantation of the aortic endograft.Operative findings included an expanding aneurysm with a type ii endoleak attributed to bleeding lumbar arteries.A midline laparotomy was performed with exposure of the infrarenal aorta and bilateral common iliac arteries.The aneurysm sac was opened, and the iliac limbs and main body of the endograft were completely removed.Reconstruction was performed using a 24-mm rifampin-soaked dacron tube graft sewn end-to-end to the proximal and distal aorta with running prolene sutures.Hemostasis was achieved with additional suturing as needed, and the aneurysm sac was closed over the graft.The abdomen was closed with looped pds sutures and skin staples.Estimated blood loss was 750 ml, with 600 ml returned via cell saver.No complications were reported.Code 5700-c: -aneurysm enlargement - other/unknown used to capture unknown degree of enlargement.
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.H6: code b20 - the device was discarded at the facility and, therefore, was not available for direct analysis by gore.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.

• 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: brittany pettengill ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 25137664
• Report Number: 3007284313-2026-04770
• Device Sequence Number: 9542788
• Product Code: MIH
• UDI-Device Identifier: 00733132610648
• UDI-Public: (01)00733132610648(17)140930
• 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: 2012
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 05/11/2026

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 Expiration Date: 09/30/2014
• Device Catalogue Number: RMT261416
• 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: 04/21/2026
• Initial Report FDA Received Date: 05/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2011
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: MEDICATIONS: LISINOPRIL, AMLODIPINE BESYLATE, ATOR.
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 95 KG