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

Catalog Number	PLC121400
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	04/01/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
D.10.Concomitant medical products and therapy dates: asked but unavailable.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) 2024, the patient underwent endovascular treatment of an abdominal aortic aneurysm and right common iliac artery aneurysm using a cxt321414 gore® excluder® conformable aaa endoprosthesis.A plc121400 gore® excluder® aaa contralateral leg component was implanted most distal in the patient's right common iliac artery.On (b)(6) 2025, a distal type i endoleak was observed in the patient's right common iliac artery.Aneurysm growth was observed (amount unavailable).On the same day a reintervention was performed whereby a gore® excluder® iliac branch component was implanted in the patient's right common iliac artery and a gore® viabahn® vbx balloon expandable endoprosthesis was implanted in the right internal iliac artery.The endoleak was resolved at the close of the procedure.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
H.6.Health effect - clinical code: code e050102 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 conclusions: code d16 updated to code d15.H.6.Investigation conclusions: code d15 - there is insufficient information available for gore to reasonably draw conclusions related to aspects of the event, therefore conclusion code ¿d15: cause not established¿ is being used.Insufficient information may include limited or missing relevant medical records, involvement of multiple implanted devices (including non-gore devices) in the field of treatment, patient non-compliance, and/or a general lack of available detail or specificity related to an adverse event and/or device.H.6.Investigation conclusions: code d12 added.According to the gore® excluder® aaa endoprosthesis instructions for use, potential device or procedure related adverse events that may occur and/or require intervention or additional intraoperative procedure time include, but are not limited to, endoleak and aneurysm enlargement.
Additional Manufacturer Narrative
D.10.Concomitant medical products and therapy dates: added.D.10.Concomitant medical products and therapy dates: amitriptyline, apixaban, aspirin, atorvastatin, cholecalciferol, digoxin, fluticasone/umeclidinium/vilanterol, folic acid, lisinopril, metoprolol, pantoprazole, tiotropium, verapamil, albuterol prn, acetaminophen prn, ibuprofen prn, ipratropium-albuterol prn.H.6.Investigation conclusions: codes d15 and d12 remain 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21938434
• Report Number: 3013164176-2025-02499
• Device Sequence Number: 12733654
• Product Code: MIH
• UDI-Device Identifier: 00733132618644
• UDI-Public: (01)00733132618644(17)270321
• Combination Product (Y/N): N
• Initial Reporter State: AL
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• 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,Followup,Followup
• Report Date (Section B): 07/28/2025

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: PLC121400
• 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: 04/01/2025
• Supplement Date Received by Manufacturer: 05/01/2025; Not provided
• Initial Report FDA Received Date: 04/30/2025
• Supplement Report FDA Received Date: 05/31/2025; 07/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/22/2024
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SEE H10 FOR LIST OF MEDICATIONS
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 69 YR
• Patient Sex: Male
• Patient Weight: 118 KG