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

Catalog Number	RLT351414
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	06/17/2015
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remain implanted and are not available for analysis.Also was implanted: plc18120/(b)(6) udi# (b)(4), plc181000/(b)(6) udi# (b)(4).Code f28 was used to cover that based on the study data, no treatment was performed.Code f24 was used to cover that it is unknown how the aneurysm enlargement was treated.Code a26 was used to cover that the cause of aneurysm enlargement is unknown.Further information was requested.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 through the global registry for endovascular aortic treatment (great 10-11): on (b)(6) 2014, this patient underwent endovascular treatment for an abdominal aortic aneurysm with gore® excluder® aaa endoprosthesis devices.The patient tolerated the procedure.Pre-treatment aortogram showed that the maximum diameter of the aortic aneurysm/lesion was 56.9mm.The follow up computed tomography angiography (cta) showed that from (b)(6) 2015 to (b)(6) 2018 the maximum diameter of the aortic aneurysm/lesion increased from 55mm to 66mm.It was reported that the aneurysm enlargement was determined on imaging during the hospitalization for hematuria due to subsequent diagnosis of bladder cancer.Reportedly, no treatment was performed to fix the aneurysm enlargement.
Additional Manufacturer Narrative
H.6.Code c19: a review of the manufacturing records for the devices verified the lots met all pre-release specifications.The devices remained implanted and were not available for analysis.Also was implanted: plc18120/(b)(6) udi# (b)(4).Plc181000/(b)(6) udi# ((b)(4).Code f28 was used to cover that based on the study data, no treatment was performed.The event was ongoing.Code f24 was used to cover that the physician was monitoring the aneurysm enlargement.Code a26 was used to cover that the cause of aneurysm enlargement was unknown.The cause of aneurysm enlargement remains unknown.Additional information was requested, however, was not available.

• 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 MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22442830
• Report Number: 2017233-2025-06395
• Device Sequence Number: 8018016
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: (01)00733132618477(17)170228
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2014
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Study
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 07/28/2025

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: 02/28/2017
• Device Catalogue Number: RLT351414
• 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: 06/20/2025
• Supplement Date Received by Manufacturer: 07/28/2025
• Initial Report FDA Received Date: 07/08/2025
• Supplement Report FDA Received Date: 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/24/2014
• 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: Other; Hospitalization
• Patient Age: 87 YR
• Patient Sex: Male
• Patient Weight: 67 KG
• Patient Race: White