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

Catalog Number	PXC181000
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Migration (4003)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	06/29/2011
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional device will be identified in this report: catalog #pxc181000, serial # (b)(6), udi (b)(4).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.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) 2011, this patient underwent an endovascular treatment for abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.The final angiography showed a remaining type ii endoleak, but it was left for monitoring.In (b)(6) 2025, a ct scan showed aneurysm enlargement due to type ii endoleak, and aneurysmorrhaphy was planned.However, it was then found that the right contralateral leg had migrated proximally, leaving only about 2 mm of landing zone in the iliac artery.Therefore, additional evar was planned to be performed prior to the aneurysmorrhaphy.On (b)(6) 2026, a reintervention was performed.Another contralateral leg was placed distal to extend the treatment area for 2 cm.Thereafter, aneurysmorrhaphy was performed.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: investigation findings and conclusions were updated to reflect the results of investigation.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.

• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: tatsuya sato ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24566350
• Report Number: 2017233-2026-07247
• Device Sequence Number: 9500050
• Product Code: MIH
• UDI-Device Identifier: 00733132610006
• UDI-Public: (01)00733132610006(17)140331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/31/2026

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: 03/31/2014
• Device Catalogue Number: PXC181000
• 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: 02/16/2026
• Supplement Date Received by Manufacturer: 03/21/2026
• Initial Report FDA Received Date: 03/11/2026
• Supplement Report FDA Received Date: 03/31/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/19/2011
• 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: 60 YR
• Patient Sex: Male