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

Catalog Number	CXT361414
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/12/2025
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 endoprosthesis.It was reported that the deployment line was broken.At this point using the back up mechanism was no longer an option.The physician proceeded with the surgery by deploying the second stage of the device and successfully removing the catheter from the body.The constraining loop line was removed along with the catheter.The device was able to be fully deployed.The patient tolerated the procedure.The cause of the reported event is 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.Corrected b5.The imaging evaluation determined the following: three radiographic jpeg images were provided for evaluation.There was no name, date, or demographics on the images.The images cannot manipulated in any way.(window leveling, rotating, etc.).The diameter or length measurements cannot be provided with the jpeg images.The jpeg imaging provided for evaluation shows a non-gore extender/cuff is implanted within the proximal end of a gore® excluder® conformable aaa endoprosthesis.The gore® excluder® conformable aaa endoprosthesis appears to be fully expanded on the second jpeg image.Deployment handle/knob/line event cannot be confirmed, especially if the event happens outside of the radiographic field of view.The last jpeg image appears to show an undeployed device is advanced to a level proximal to the renal arteries.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.
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 endoprosthesis.It was reported that the constraining loop broke from the transparent knob.At this point using the back up mechanism was no longer an option.The physician proceeded with the surgery by deploying the second stage of the device and successfully removing the catheter from the body.The constraining loop line was removed along with the catheter.The device was able to be fully deployed.The patient tolerated the procedure.The cause of the reported event is unknown.

• 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: 22394854
• Report Number: 3007284313-2025-04074
• Device Sequence Number: 9160852
• Product Code: MIH
• UDI-Device Identifier: 00733132651078
• UDI-Public: (01)00733132651078(17)271124
• Combination Product (Y/N): N
• Initial Reporter State: CO
• 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: CXT361414
• 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: 06/12/2025
• Supplement Date Received by Manufacturer: 08/08/2025
• 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: 11/25/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 88 YR
• Patient Sex: Unknown