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

Catalog Number	PXT261216
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	12/07/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.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
On (b)(6) 2010, the patient underwent endovascular treatment of a zone 9 abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.A pxt261216 trunk-ipsilateral leg component and pxc141200 contralateral leg component were implanted.On (b)(6) 2024, it was reported that the patient presented with a possible proximal type i or type ii endoleak affecting the pxt261216, and a possible distal type i endoleak in the right common iliac artery.It was noted that the right iliac artery was dilated and the device was not opposed to the vessel wall.Angiography was performed, and a small endoleak was observed proximally.The device was ballooned with a gore® molding & occlusion balloon catheter.The endoleak was still present so a gore® excluder® aaa aortic extender component was implanted proximally.The aortic extender was ballooned and the endoleak remained.The physician was reportedly unable to confirm whether the endoleak was a proximal type i or type ii.The physician extended the device in the right common iliac artery using another device to extend into the distal common iliac artery.No further endoleak was observed distally.There were no further reported issued.The patient tolerated the procedure.
Additional Manufacturer Narrative
A.4.Patient weight: asked but unavailable.B.7.Other relevant history, including preexisting medical conditions: asked but unavailable.D.10.Concomitant medical products and therapy dates: albuterol 90 mcg/inh 2 puffs prn, amlodipine 10 mg od, apixaban 5 mg bid, aspirin 81 mg od, atorvastatin 40 mg od, calcium citrate 950 mg bid, carvedilol 25 mg bid, cholecalciferol 25 mcg bid, citalopram 20 mg od, cyanocobalamin 1000 mcg od, cyclosporine ophthalmic 2 drops qid, docusate 100 mg prn, empagliflozin 10 mg qam, famotidine 20 mg od, fluticasone 200 mcg od, furosemide 40 mg od, hydroxyzine hydrochloride 10 mg od, insulin aspart 7 units tidmw, insulin detemir 10 units bid, losartan 100 mg od, megestrol 800 mg od, metformin 850 mg bid, mometason 1 puff bid, nitroglycerin 0.4 mg prn, pantoprazole 40 mg, polyethylene glycol 3350 17g od, quetiapine 12.5 mg od.G.4.Pma/510(k)number added.H.6.Investigation findings for analysis of production records: code c21 updated to code c19.H.6.Investigation findings for analysis of production records: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.H.6.Investigation findings for imaging evaluation: code c21 updated to code c19.H.6.Investigation findings for imaging evaluation: code c19 - the imaging evaluation was performed by a clinical imaging specialist and showed the following: one time-point available for evaluation - post-implantation cta dated (b)(6) 2024.The left renal artery (lra) is the lowest renal artery.The aortic diameter just distal to the lra appears to be 24.3mm.The aortic diameter approximately 8mm distal to the lra appears to be 25.1mm.The aortic diameter 15mm distal to the lra appears to be 26.1mm.There appears to be seal in this 15mm of abdominal aorta.Thereby, ruling out a proximal type i endoleak.There appears to be lack of distal circumferential device apposition in the right common iliac artery (rci).Thereby, confirming a distal type i endoleak.Rci diameters appear to range from 13.2mm ¿ 19.5mm.Axial image shows contrast pooling in the posterior aneurysm sac - communication with a lumbar artery.Thereby, confirming a type ii endoleak involving a set of lumbar arteries.Comparison axial series imaging (non-contrast, arterial contrast, and delayed contrast) shows that there is contrast pooling in the aneurysm sac outside the implanted devices.The size of the pooling contrast is increased on the delayed contrast images.This finding is consistent with a type ii endoleak.H.6.Investigation conclusions: code d16 updated to code d12.According to the gore® excluder® aaa endoprosthesis instructions for use, potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak.Furthermore, the ifu informs users of the risks associated with type ii endoleaks, and users are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #pxc141200/ serial #(b)(6)/ udi #(b)(4) which has been captured in manufacturer report #2953161-2025-01230.H.6.Investigation conclusions: code d12 remains unchanged.

• Brand Name: GORE® EXCLUDER® 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21086157
• Report Number: 2953161-2025-01231
• Device Sequence Number: 6916432
• Product Code: MIH
• UDI-Device Identifier: 00733132610198
• UDI-Public: 00733132610198
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2010
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/31/2025

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: 05/31/2012
• Device Catalogue Number: PXT261216
• 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: 12/07/2024
• Supplement Date Received by Manufacturer: 01/08/2025; 03/31/2025
• Initial Report FDA Received Date: 01/06/2025
• Supplement Report FDA Received Date: 02/06/2025; 03/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 06/15/2009
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Male