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

Catalog Number	PLC121000
Medical Device Problem Codes	Microbial Contamination of Device (2303); Patient Device Interaction Problem (4001)
Health Effect - Clinical Codes	Bacterial Infection (1735); Medical device site infection (4845)
Date of Event	10/06/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6.Code c19: a review of the manufacturing records of the device indicated the lot met all the pre-release specifications.The device was explanted and is not available for analysis.Please note that a gore® excluder® conformable aaa endoprosthesis (cxt321414e/ (b)(6)) device was reported separately.Reportedly, salmonella species was the isolated microorganism in all his microbiologic specimens.All devices were explanted.No new gore devices were implanted.The patient completed the study.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 was reported to gore on (b)(6) 2025, from the imedidata study database and imaging email: on (b)(6) 2025, the patient underwent endovascular treatment for an abdominal aortic aneurysm using a gore®excluder®conformable aaa endoprosthesis device and gore®excluder®aaa endoprosthesis devices.The gore® devices were successfully implanted.The patient tolerated the procedure without complications.The patient was discharged home on (b)(6) 2025.On (b)(6) 2025, the patient experienced infection related to gore®excluder® devices.Reportedly, salmonella species was the isolated microorganism in all his microbiologic specimens.The patient had a medication treatment using ceftriaxone 2g daily.Additionally, the patient had iv blood test and a cta.The scan revealed the increasing inflammatory changes around the aortic stents.All three devices were infected.Repair with a small abscess collection forming within this.On (b)(6) 2025, all devices were explanted and right axillary bifemoral graft (open surgery) was used.No new gore devices were implanted.The patient completed the study.The patient was discharged from the critical care on (b)(6) 2025 and is stable, recovering on iv antibiotics.The event is ongoing.
Additional Manufacturer Narrative
Additional information: h6.Code c19: a review of the sterilization records of the device indicated the lot met all the pre-release specifications.H6.Code c19: a review of the manufacturing records of the device indicated the lot met all the pre-release specifications.The device was explanted and is not available for analysis.Please note that a gore® excluder® conformable aaa endoprosthesis (cxt321414e/ 28998955) device and a gore® excluder® aaa endoprosthesis (pll161407/ 28761302) device were reported separately.Reportedly, salmonella species was the isolated microorganism in all his microbiologic specimens.All devices were explanted.No new gore devices were implanted.The patient completed the study.

• 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: nataliya baramzina ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 23420814
• Report Number: 3013164176-2025-02730
• Device Sequence Number: 15918556
• Product Code: MIH
• UDI-Device Identifier: 00733132618613
• UDI-Public: (01)00733132618613(17)260618
• Combination Product (Y/N): N
• Initial Reporter Country: NZ
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Device Explanted Year: 2025
• 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): 11/10/2025

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: 06/18/2026
• Device Catalogue Number: PLC121000
• 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: 10/16/2025
• Supplement Date Received by Manufacturer: 11/07/2025
• Initial Report FDA Received Date: 10/29/2025
• Supplement Report FDA Received Date: 11/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/20/2023
• 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: Hospitalization; Required Intervention; Other
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 83 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White