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

Catalog Number	PLC161000
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/25/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
A.2.Age at the time of event/date of birth: asked but unavailable.A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.D.10.Concomitant medical products and therapy dates: asked but unavailable.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.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
On (b)(6) 2022, the patient underwent endovascular treatment of an infrarenal abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A plc161000 contralateral leg component was implanted in the patient's right common iliac artery.It was reported that the patient presented on (b)(6) 2025, with a distal type i endoleak from the right limb.The right common iliac artery had reportedly dilated due to disease progression.The physician plans to embolize the right internal iliac artery and extend into the external iliac artery with a pll161007 gore® excluder® aaa iliac extender component at a later date.
Additional Manufacturer Narrative
H.6.Investigation findings for imaging evaluation: code c21 updated to code c19.H.6.Investigation conclusions: code d16 updated to code d1001.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use, potential device or procedure-related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak.
Additional Manufacturer Narrative
A.2.Patient dob: added.B.3.Date of event: as the post-implantation cta identifying the distal type i endoleak was performed on (b)(6) 2025, this date has been used as the updated estimated date of event.B.5.Event description: additional information added.H.6.Investigation findings for imaging evaluation: code c19 - one post-implantation cta time-point was provided for analysis, dated (b)(6) 2025.Axial images showed contrast pooling in the distal aneurysm sac into the right common iliac artery (rci).The length from the distal limb in the rci to the right iliac bifurcation appeared to be ~10mm by centerline.There was a lack of distal circumferential device apposition in the rci, thereby confirming a distal type i endoleak.H.6.Investigation conclusion: codes d12 and d1001 remain unchanged.
Event or Problem Description
On (b)(6) 2025, a reintervention was performed whereby the patient's right internal iliac artery was embolized and a plc121400 gore® excluder® aaa endoprosthesis contralateral leg component was used to extend into the patient's right external iliac artery.There were no further reported issues.

• 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: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21944320
• Report Number: 3013164176-2025-02502
• Device Sequence Number: 8799807
• Product Code: MIH
• UDI-Device Identifier: 00733132618668
• UDI-Public: (01)00733132618668(17)250320
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 07/30/2025

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: 03/20/2025
• Device Catalogue Number: PLC161000
• 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: 04/02/2025
• Supplement Date Received by Manufacturer: 06/17/2025; Not provided
• Initial Report FDA Received Date: 05/01/2025
• Supplement Report FDA Received Date: 06/17/2025; 07/30/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2022
• 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: Required Intervention
• Patient Age: 85 YR
• Patient Sex: Female