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

Catalog Number	PLC141400
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	05/07/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, patient underwent an endovascular procedure to treat an abdominal aortic aneurysm, utilizing gore® excluder® aaa endoprosthesis (rlt261418 and plc141400).On (b)(6) 2022, patient underwent an reintervention surgery to treat a type ii endoleak.On (b)(6) 2025, a ct revealed a recurrent type ii endoleak.On (b)(6) 2025, patient underwent a transcaval embolization due to this recurrent type ii endoleak.During reintervention surgery, a type 1b endoleak was also noted in the right iliac limb.On (b)(6) 2025, patient underwent a reintervention surgery to treat the type 1b endoleak, in which a plc device was implanted to extend the right iliac.It was also reported the type1b endoleak was resolved, and the type ii endoleak remained.Physician will continue to monitor this type ii endoleak.Fsa was notified of previous reinterventions (b)(6) 2022 and (b)(6) 2025) on (b)(6) 2025, and does not have any further information, as he was not present.The cause of the persistent type ii endoeak as per physician, is due to patient factors, with no specific cause.
Additional Manufacturer Narrative
H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.No device problem was found per review of these records.H6: code b20 ¿ the device remains implanted and, therefore, was not available for direct analysis by gore.The following patient information was provided: medical history: hypertension diabetes.Medication: metforman, glipizide, coreg cr, eliquis, crestor, citilopram, aspirin.It should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22134353
• Report Number: 3013164176-2025-02540
• Device Sequence Number: 7356907
• Product Code: MIH
• UDI-Device Identifier: 00733132618651
• UDI-Public: (01)00733132618651(17)210320
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 06/03/2025

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: 03/20/2021
• Device Catalogue Number: PLC141400
• 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: 05/07/2025
• Initial Report FDA Received Date: 06/03/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/21/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG