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

Catalog Number	PLC161400
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	08/15/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one timepoint is available for evaluation: post implantation cta dated (b)(6) 2025.¿ the length from the left renal artery (lra) to the proximal circumferential device appears to be ~10.5mm, by centerline.¿ aortic diameters appear to range from 20.6mm ¿ 27.8mm.¿ cannot confirm contrast outside the proximal end of the implanted device.¿ therefore, cannot confirm a type ia endoleak.¿ there appears to be irregular calcium in the flow lumen and irregular flow lumen ~9.5mm distal to the distal end of the implanted device leg in the rci.¿ contrast is not visualized outside the level of the implanted device in the rci.¿ therefore, cannot confirm a type ib endoleak.¿ comparison series (non-contrast, arterial contrast, delayed contrast) axial images show: - the non-contrast axial series appears to show contrast outside the proximal end of the implanted device however, there is no contrast on the images in this series.- next set of images shows again, there is increased density surrounding the implanted device on the non-contrast series.- the maximum diameter of the aaa appears to be 73.7mm x 75.5mm on the delayed contrast series.- there appears to be an increased density around the implanted devices, even on the non-contrast image set.- the increased density does not match the contrast density inside the implanted devices on the arterial contrast image.This finding suggests that the density outside the devices is not contrast.- there appear to be increased densities on the non-contrast image at another level.- there appears to be contrast pooling in the right side of the abdominal aorta aneurysm sac on the delayed contrast image series.- there is a possible faint pooling of contrast on the arterial contrast image in the same area.- increased pooling contrast, on the delayed contrast image, is indicative of a type ii endoleak.However, cannot confirm the origin of the endoleak with available images.- endoleak of unknown origin.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) 2020, patient underwent an endovascular procedure to treat an unknown application utilizing a gore® excluder® aaa endoprosthesis (trunk ipsilateral leg c3 and contralateral leg).On (b)(6) 2025, field sales associate (fsa) was notified by the physician that there is a type 1a and 1b endoleak on the patient's right side with an excluder graft.On (b)(6) 2025, additional information received that there is a confirmed type 1a endoleak based on ct scans as aneurysm has grown to 7cm.Physician is planning a reintervention but procedural details and date has not been decided yet.

• 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: 23015590
• Report Number: 3013164176-2025-02667
• Device Sequence Number: 21269091
• Product Code: MIH
• UDI-Device Identifier: 00733132618729
• UDI-Public: (01)00733132618729(17)210823
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• 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): 09/10/2025

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: 08/23/2021
• Device Catalogue Number: PLC161400
• 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: 08/15/2025
• Initial Report FDA Received Date: 09/10/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/24/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male