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 Code	Material Deformation (2976)
Health Effect - Clinical Codes	Ischemia (1942); Multiple Organ Dysfunction Syndrome (3261); Embolism/Embolus (4438); Thrombosis/Thrombus (4440)
Date of Event	03/16/2026
Type of Reportable Event	Death
Event or Problem Description
It was reported to gore that on (b)(6) 2026, the patient underwent endovascular treatment for an iliac artery aneurysm using the gore® excluder® conformable aaa endoprosthesis and the gore® excluder® aaa endoprostheses; after deployment of the trunk ipsilateral leg, cannulation of the contralateral limb was attempted but failed.Inadequate deployment of the contralateral gate (collapse due to aortic angulation) was observed.The physician attempted to rotate the device using the constraining system to adjust the orientation of the gate; however, the gate became further collapsed and could not be cannulated.Consequently, a pull through was created via the right brachial approach.During creation of the pull through, the guidewire became entangled several times, and it took approximately 30 minutes to complete.Subsequently, the catheter was advanced toward the contralateral gate, but this was unsuccessful, and the physician deployed the ipsilateral limb first.The pull through wire had become entangled with the ipsilateral limb; however, after removal of the wire and release of the pull through, cannulation was successfully achieved.Deployment of all stent graft components, including the contralateral leg, proceeded without further issues.At the time of wound closure, decreased blood flow to the right lower extremity was noted.This was considered to be attributable to thrombus embolization from the descending aorta, caused by manipulation of the guidewire and angiographic catheter during creation of the pull through.The patient tolerated the procedure.On (b)(6) 2026, it was reported that the patient passed away due to multiple organ failure.The cause was determined to be thrombus embolization that occurred during creation of the pull-through.
Additional Manufacturer Narrative
H6: a review of the manufacturing records indicated 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: eimi ueda ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 24867397
• Report Number: 3007284313-2026-04703
• Device Sequence Number: 18392127
• Product Code: MIH
• UDI-Device Identifier: 00733132651030
• UDI-Public: (01)00733132651030(17)281207
• 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
• 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): 04/14/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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: 03/27/2026
• Initial Report FDA Received Date: 04/13/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 12/09/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death
• Patient Age: 83 YR
• Patient Sex: Male