MAUDE Adverse Event Report: W. L. Gore & Associates, Inc. GORE® EXCLUDER® Conformable AAA Endoprosthesis; System, Endovascular Graft, Aortic Aneurysm Treatment

Catalog Number	CXT261412
Medical Device Problem Codes	Malposition of Device (2616); Material Deformation (2976)
Health Effect - Clinical Code	Obstruction/Occlusion (2422)
Date of Event	07/31/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
The following information was reported to gore: on (b)(6) 2026, a patient underwent an endovascular procedure to treat an abdominal aortic aneurysm using a gore® excluder® conformable aaa endoprosthesis device.When guidewire insertion into the contralateral gate of the trunk-ipsilateral leg was attempted, it was difficult.The left leg of the trunk-ipsilateral leg near the flow divider was found to be compressed.The physician attempted to apply tension to the pull-through guidewire to press the device against the vessel at the compressed area; however, the guidewire could not advance through the compressed area.Then the physician removed the clear knob and deployed the ipsilateral leg, and attempted to access the contralateral gate from the proximal side; however, the guidewire still could not advance.Also, a 0.014-inch guidewire was used to gain access, but it also could not advance.The physician attempted ballooning of the ipsilateral leg and used a micro guidewire from distal; however, all attempts failed to advance the guidewire into the contralateral gate.The physician decided to abandon the procedure considering the fluoroscopy time and radiation dose.The procedure was completed with only the trunk-ipsilateral leg deployed, and both legs were in the aneurysm.Angiography revealed that there was no flow in the right renal artery.It was unknown whether a thrombus was present or the trunk-ipsilateral leg had covered the right renal artery.The patient tolerated the procedure.On (b)(6) 2026, an open surgery was performed to remove the trunk-ipsilateral leg and convert it to a y-graft.
Additional Manufacturer Narrative
H6: a review of the manufacturing records for the device verified that the lot 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.

• 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 Phoenix 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: mana yamamoto ; 1505 n. fourth street; flagstaff, AZ 86004 ; +1(928)526-3030
• MDR Report Key: 50424279
• Report Number: 3007284313-2026-05029
• Device Sequence Number: 18415697
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: (01)00733132651030(17)290331
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2026
• Device Explanted Year: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 08/25/2026

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: CXT261412
• 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: 07/31/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/02/2026
• 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: Male