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	Material Integrity Problem (2978)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/18/2025
Type of Reportable Event	Malfunction
Event or Problem Description
The field sales associate (fsa) reported the following to gore: on (b)(6) 2025, the patient underwent an endovascular procedure to treat an aneurysm utilizing the gore® excluder® conformable aaa endoprosthesis.It was reported that the aortic extender did not deploy as intended.The procedure was performed emergently due to a ruptured abdominal aortic aneurysm (aaa), and the infrarenal neck did not meet the optimal criteria outlined in the instructions for use (ifu), measuring approximately 6 to 7 mm in length.Upon full deployment, the extender did not align coaxially with either the ipsilateral limb or the aorta.The deployment occurred slightly faster than the fsa would have preferred.The device appeared distorted on the proximal and distal end, exhibiting signs of infolding and/or scruching.To address this, an additional proximal aortic extender was placed, and ballooning was performed throughout the system.There was no unintentional coverage of adjacent vessels.There was no patient harm or adverse event.The physician does not believe the issue was due to anatomical constraints.At the distal site of infolding, there were no significant angulations.The root cause of the deployment issue remains unknown.
Additional Manufacturer Narrative
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.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6 the imaging evaluation determined the following: five jpeg radiographic images were provided for evaluation.The images did not have name, date, or demographics.The images prevented manipulation such as window leveling, rotation, or measurement of diameter and length.Image 1: shows one non-deployed aortic extender, identifiable by three long radiopaque markers, advanced to the level of the renal arteries.Image 2: the long radiopaque markers do not appear to be parallel.The wire pattern also appears distorted/unaligned.Image shows contrast proximal to the proximal end of the devices.It cannot be confirmed if there is a blockage within the proximal implanted devices or if this is where the timing of the bolus was image 3: the image continues to show non-aligned long proximal markers of the aortic extender.Image 4: a marker pigtail catheter is present.Only one aortic extender appears to be implanted.Image 5: shows a second aortic extender being implanted and ballooned.The unaligned first radiopaque markers appear to be the same.However, the markers of the second aortic extender appear to be somewhat parallel to each other and there does not appear to be wire distortion at the proximal end of the 2nd aortic extender.The images received cannot be used to perform a full imaging evaluation because they do not meet the dicom standard.The extent and accuracy of the observations and findings may be limited due to the completeness, format and/or quality of the images provided for review.Gore cannot guarantee all key findings have been captured or that the findings are accurate.

• 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: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 22395245
• Report Number: 3007284313-2025-04075
• Device Sequence Number: 21122280
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: (01)00733132650972(17)280129
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2025
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/08/2025

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?: Yes
• 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: 06/18/2025
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 07/03/2025
• Supplement Report FDA Received Date: 08/08/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/30/2025
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Female