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

Catalog Number	RLT281418
Medical Device Problem Codes	Material Invagination (1336); Device Endoleak (4074)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Clinical Endoleak (4843)
Date of Event	10/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to gore, that on (b)(6) 2025, a patient was treated with gore® excluder® aaa endoprosthesis devices for abdominal and iliac aneurysm.Significant thrombus was measured in the proximal aortic neck (7 mm and 50% of the vessel circumference in the intended seal zone).The aneurysm in the left common iliac artery also had significant thrombus with minimal true lumen and narrow internal iliac artery (which lead to the decision to overstent/embolize the internal iliac artery).A follow-up ct on (b)(6) 2025 showed a collapse/infolding of the proximal part of the gore® excluder® aaa endoprosthesis (trunk ipsilateral component rlt281448), leading to a type 1a endoleak.The ct also showed that both the left (plc121000) and the right (plc231400) contralateral leg components of the gore® excluder® aaa endoprosthesis were thrombosed.On an unknown date, a reintervention was performed on the gore® excluder® aaa endoprosthesis (right contralateral leg device (plc231400)) involving thrombectomy, as well as dilation of the proximal neck for the rlt281448.Reportedly, a full proximal expansion of the rlt281448 was not achievable.A new control ct on (b)(6) 2025 still showed a proximal collapse and persistent thrombosis in the left limb.The right limb remains patent.A second reintervention was performed on (b)(6) 2025.A begraft balloon-expandable stent with a diameter of 24 mm (bentley) was placed at the proximal end of the gore® excluder® aaa endoprosthesis trunk device, then dilated and sealed completely.This was successful.A thrombectomy was performed on the left contralateral leg components of the gore® excluder® aaa endoprosthesis (plc121000), using a fogarty balloon catheter.Due to the conditions of the left common iliac artery, thrombus remains but the patient is symptom-free.No additional reintervention is currently planned.
Additional Manufacturer Narrative
D10: concomitant medical products: (relevant associated devices used with the device being reported on): gore® excluder® aaa endoprosthesis (contralateral leg components): left (plc121000) and the right (plc231400).As part of our routine quality procedures, each batch of devices undergoes comprehensive quality control testing and inspections prior to release for distribution.Gore reviewed the manufacturing records associated with the reported lot number and verified that all release criteria had been met.Imaging evaluation is ongoing.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.
Additional Manufacturer Narrative
Updated h6: added health effect - clinical code e2328.Updated investigation findings code to c23 and c070601, code c21 is no longer applicable.Updated investigation conclusions code to d1102, code d16 is no longer applicable.The primary reported device failure mode, collapse or infolding at the proximal end of the implanted gore® excluder® aaa endoprosthesis within one month of initial implant leading to a type ia endoleak, is consistent with evaluation of the provided clinical images.The imaging evaluation shows compression and occlusion at the proximal end of the endoprosthesis allowing contrast to pass outside the endoprosthesis.The imaging evaluation also confirms the report of significant thrombus present in the patient¿s aorta at the endoprosthesis landing zone.The device instructions for use (ifu) indicate significant thrombus within the anatomy may affect successful aneurysm exclusion and, therefore, include minimal thrombus within the proximal aortic neck as a requirement.The order of occurrence of the reported complications, whether the endoleak preceded the collapse or vice versa, could not be established with the available information, but the cause for both may be attributed to use of the device within anatomy having significant thrombus as reported.

• 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: ida simson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23565430
• Report Number: 3007284313-2025-04368
• Device Sequence Number: 16003941
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: (01)00733132622559(17)271007
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• 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): 02/11/2026

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 Catalogue Number: RLT281418
• 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: 11/04/2025
• Supplement Date Received by Manufacturer: 02/11/2026
• Initial Report FDA Received Date: 11/16/2025
• Supplement Report FDA Received Date: 02/11/2026
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 10/08/2024
• 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: Other
• Patient Age: 73 YR
• Patient Sex: Male