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

Catalog Number	CXA360005
Medical Device Problem Code	Entrapment of Device (1212)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	01/29/2025
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2021, this patient underwent endovascular treatment for infrarenal abdominal aortic aneurysm and was implanted with gore® excluder® aaa endoprosthesis featuring c3® deployment system (rlt351414/ (b)(6).The patient tolerated the procedure.On (b)(6) 2024, the patient underwent reintervention for a proximal type i endoleak.A snorkel/chimney procedure was performed with placement of a gore® excluder® conformable aortic extender endoprosthesis cxa360005/ (b)(6) and a gore® viabahn® vbx balloon expandable endoprosthesis (vbx device).The vbx device was extended into the left renal artery.The patient tolerated the procedure and the endoleak was resolved.On (b)(6) 2025, the physician provided imaging to gore for evaluation of a proximal type i endoleak/gutter leak.The leak appears to originate around where the stent (bxb065902a/ (b)(6) travels north of the a gore® excluder® conformable aortic extender endoprosthesis into the left renal artery.Additionally, aneurysm enlargement from 5.5 cm to 6.2 cm is indicated on the radiology report.At this time there is no reintervention scheduled or planned for the patient.The event is ongoing.
Additional Manufacturer Narrative
The instructions for use (ifu) for the gore® excluder® conformable aaa endoprosthesise states, adverse events that may occur and / or require intervention or additional intraoperative procedure time include, but are not limited to: endoleak, aneurysm enlargement.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.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.
Additional Manufacturer Narrative
E1: additional information: images were provided to gore for evaluation and showed the following: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time point available for evaluation: post-implantation cta dated (b)(6)2025.¿ 3d images show there is contrast outside the implanted devices.¿ axial image shows contrast outside the stent in the aorta and left renal artery.¿ the length from the left renal artery to the contrast pooling in the sac appears to be 15.9mm, by centerline.¿ there is a right accessory renal artery distal to the level of the left renal artery.¿ the length from the right accessory renal artery to the contrast pooling in the sac appears to be 13.0mm, by centerline.¿ cannot confirm with available imaging if this is a type i (gutter) endoleak or a type ii involving a lower right accessory renal artery.¿ endoleak of unknown origin.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21316096
• Report Number: 3013164176-2025-02376
• Device Sequence Number: 12870529
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: (01)00733132650972(17)270610
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 02/12/2025

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: CXA360005
• 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: 01/29/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 02/05/2025
• Supplement Report FDA Received Date: 02/12/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/11/2024
• 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: Other
• Patient Age: 84 YR
• Patient Sex: Male