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

Catalog Number	CXA230005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	02/09/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Since it is unknown which device is directly implicated in this complaint, cxa230005 / sn# (b)(6) will be included in the report.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Imaging evaluation summary: the imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6)2025.Imaging appears to show 2 - aortic extenders are implanted in the abdominal aorta.Axial imaging appears to demonstrate blurry aortic margins.Blurry aortic borders can be a sign of aortic rupture.There is contrast in the ima communicating with the aneurysm sac.The ima is close to the distal end of the implanted devices.Questionable contrast pooling in the aneurysm sac at this level.No non-contrast or delayed contrast series to compare.(non-contrast imaging would confirm if there were pooling contrast on this arterial contrast image series.Also, delayed contrast series usually shows an increase in pooling contrast in the sac if there is a type ii endoleak.) therefore, cannot confirm if there is an endoleak with available imaging.Radiopaque markers show the device locations.Overlap of the 2 devices appears to be 1.25cm, by centerline length.Flow lumen diameters at the levels of the aortic extender #1 appear to range from 19.2mm ¿ 21.0mm.Flow lumen diameters at the levels of the aortic extender #2 appear to range from 19.0mm ¿ 23.0mm.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), potential adverse events that may occur and/or require intervention include but are not limited to endoleak and aneurysm enlargement.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 have not 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 following was reported to gore: on (b)(6) 2024, the patient underwent an unknown endovascular procedure utilizing two gore® excluder® conformable aaa endoprosthesis.On (b)(6) 2025, the field sales associate (fsa) was notified by the physician that this patient is being brought back for a reintervention.On (b)(6) 2025, the patient underwent an endovascular reintervention utilizing a gore® tag® conformable thoracic stent graft with active control system.Reportedly, during the reintervention, physician did a realignment of the two original grafts (conformable aortic extenders) as there was no bifurcated graft implanted during the original procedure.The thoracic conformable stent graft was implanted to treat an unknown endoleak in the aneurysm sac (size of growth is unknown) as physician was not sure if its a type 2 or 3 endoleak by realigning from just below the superior mesenteric artery (sma) to almost down to aortic bifurcation in order to cover the junction between the two original grafts, as a result, the renal arteries were occluded.Physician then extended distally with a conformable cuff to gain extra landing zone towards the bifurcation.A cta follow-up (date unknown) is planned to see if the endoleak has been resolved.Patient tolerated the procedure.Physician stated that the patient is a chronic dialysis patient and they had planned to cover both the left and right renal arteries as part of reintervention procedure with the inferior mesenteric artery (ima) being patent and off-label use of the device.

• 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: parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21550430
• Report Number: 3007284313-2025-03817
• Device Sequence Number: 15483775
• Product Code: MIH
• UDI-Device Identifier: 00733132650934
• UDI-Public: (01)00733132650934(17)270112
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 03/07/2025

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 Catalogue Number: CXA230005
• 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: 02/09/2025
• Initial Report FDA Received Date: 03/07/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/14/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 66 YR
• Patient Sex: Male