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

Catalog Number	PLC161200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Abscess (1690)
Date of Event	07/07/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.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) 2024, patient underwent an endovascular procedure to treat an abdominal aortic aneurysm (aaa) utilizing a gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 and two contralateral legs).On (b)(6) 2025, physician notified the field sales associate that the patient has an abscess around the distal left common iliac artery with a drain in-situ performed (date unknown of when drain was inserted).Physician will explore surgically and plans for possible explant of the excluder limb from the left side and convert the trunk ipsilateral leg to unibody graft.There are no reported issues with the trunk ipsilateral leg.Cause of the abscess is currently unknown and also, it is currently unknown if physician has performed a surgical explant of the left contralateral limb or will do so in the future.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.H7: additional investigation determined no product problem or deficiency caused or contributed to an adverse event/incident for the patient; the initial medwatch and any supplemental report submitted under manufacturer report number 3013164176-2025-02628 was submitted in error and is hereby retracted.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22679077
• Report Number: 3013164176-2025-02628
• Device Sequence Number: 9447826
• Product Code: MIH
• UDI-Device Identifier: 00733132618705
• UDI-Public: (01)00733132618705(17)270416
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Remedial Action: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 10/01/2025

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 Catalogue Number: PLC161200
• 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: 07/07/2025
• Supplement Date Received by Manufacturer: 10/01/2025
• Initial Report FDA Received Date: 07/31/2025
• Supplement Report FDA Received Date: 10/01/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/17/2024
• 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; Other
• Patient Age: 5 YR
• Patient Sex: Male