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

Catalog Number	PLC201200
Medical Device Problem Code	Migration (4003)
Health Effect - Clinical Code	Aneurysm (1708)
Date of Event	12/31/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2015, this patient underwent planned endovascular treatment for an abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis devices.The patient tolerated the procedure.On (b)(6) 2025, the patient underwent computerized axial tomography (cat) scan imaging which showed aneurysmal dilatation distal to the originally implanted limbs on both sides.It is unknown if the limbs migrated proximally from the original placement, however the right limb is currently 21 mm proximal to the internal iliac artery and the left limb is 45 mm proximal to the internal iliac artery.On (b)(6) 2025, the patient was brought in for re-intervention and a gore® excluder® iliac branch endoprosthesis (ibe) and a gore® viabahn® vbx balloon expandable devices were implanted on both sides.A gore® excluder® contralateral leg component was also implanted on the left side left side prior to ibe placement to extend the prior limb and create a landing zone.This successfully excluded the common iliac aneurysms.The procedure was well tolerated and without complication.
Additional Manufacturer Narrative
The imaging evaluation performed by a clinical imaging specialist showed the following: two time-points available for evaluation: post-implantation cta dated (b)(6) 2025.The (b)(6) 2025 ct is a non-contrast scan.Images from the (b)(6) 2025 ct appear to show: max rci diameter appears to be 36.9mm.Max lci diameter appears to be 33.9mm.Max aaa diameter appears to be 60.8mm x 63.3mm.Images from the (b)(6) 2025 cta appear to show: max rci diameter appears to be 41.6mm.Max lci diameter appears to be 35.3mm.Max aaa diameter appears to be 58.5mm x 62.4mm.The diameters of the common iliac arteries have increased since the (b)(6) 2025 scan.The aaa diameter appears to have decreased on the (b)(6) 2025 scan.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.

• 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24483668
• Report Number: 2953161-2026-01265
• Device Sequence Number: 17394218
• Product Code: MIH
• UDI-Device Identifier: 00733132618682
• UDI-Public: (01)00733132618682(17)170930
• Combination Product (Y/N): N
• Initial Reporter State: WV
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2015
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/02/2026

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: 09/30/2017
• Device Catalogue Number: PLC201200
• 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: 02/19/2026
• Initial Report FDA Received Date: 03/02/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/08/2014
• 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; Other; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 112 KG