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

Catalog Number	CXT201412
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/31/2025
Type of Reportable Event	Serious Injury
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.
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 a ight common iliac aneurysm utilizing the gore® excluder® conformable aaa endoprosthesis (cxt) and gore® excluder® iliac branch endoprosthesis (ibe) in zone 9.There was not an abdominal aortic aneurysm.It was reported that the cxt was initially well placed just below the renal arteries.When placing the bridge limb for the ibe device, forward pressure was applied in order to shorten the length needed.The bridge limb was successfully placed.Final angiograms showed about 5 mm of proximal movement of the cxt covering the majority of the renal arteries.This was felt to be due to the forward pressure exerted when shortening the bridge limb.The flow into the renal arteries did not appear to be affected.On (b)(6) 2025, the patient was brought back and underwent successful bilateral renal artery stenting to prevent any potential complications in the future.A 6 mm x 18 mm express sd stent (non-gore device) was used in each vessel.The patient tolerated the procedure.

• 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: 21918498
• Report Number: 3007284313-2025-03935
• Device Sequence Number: 12947375
• Product Code: MIH
• UDI-Device Identifier: 00733132650996
• UDI-Public: (01)00733132650996(17)250806
• Combination Product (Y/N): N
• Initial Reporter State: WV
• 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): 05/23/2025

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 Expiration Date: 08/06/2025
• Device Catalogue Number: CXT201412
• 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: 03/31/2025
• Supplement Date Received by Manufacturer: 05/23/2025
• Initial Report FDA Received Date: 04/28/2025
• Supplement Report FDA Received Date: 05/23/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/08/2022
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: ASA, ALLOPURINOL, AZELASTINE, CETIRIZINE, FINASTER; GABAPENTIN, OMEPRAZOLE, PIOGLITAZONE, ROSUVASTATIN; SEMAGLUTIDE, SILDENAFIL, TAMSULOSIN
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 98 KG