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

Catalog Number	PXC121400
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	03/17/2025
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be 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) 2011, the patient underwent endovascular treatment of a distal type i endoleak on a previously implanted gore® excluder® aaa endoprosthesis system, as well as a reported right common iliac artery aneurysm.The endoleak and aneurysm were treated using additional gore® excluder® aaa endoprostheses, and a pxc121400 contralateral leg component was placed most distal in the patient's right common iliac artery.On (b)(6) 2025, the patient presented with a distal type i endoleak on the previously implanted contralateral leg component.A reintervention was performed whereby a plc201400 contralateral leg component and ceb231010a iliac branch component were used to extend the pxc121400.It was reported that the endoleak was resolved and the patient tolerated the procedure.
Additional Manufacturer Narrative
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: it was noted that the images received could not be used to perform a full imaging evaluation because they did not meet the dicom standard.The extent and accuracy of the observations and findings were 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.Two radiographic reconstruction images were provided for evaluation.The images were from a pre-implantation cta prior to the right common iliac/right internal iliac artery treatments were completed.The images could not be manipulated in any way (i.E.Window leveling, rotating, etc.).Diameters and/or length measurements were unable to be provided with the jpeg format.The images did include diameters taken at the imaging facility prior to being submitted to gore.Measurements could not be confirmed without dicom imaging.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.
Additional Manufacturer Narrative
A.4.Patient weight: corrected.

• 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: 21858247
• Report Number: 2953161-2025-01236
• Device Sequence Number: 4719470
• Product Code: MIH
• UDI-Device Identifier: 00733132609932
• UDI-Public: (01)00733132609932(17)140131
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 07/16/2025

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: 01/31/2014
• Device Catalogue Number: PXC121400
• 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: 03/17/2025
• Supplement Date Received by Manufacturer: Not provided; Not provided
• Initial Report FDA Received Date: 04/17/2025
• Supplement Report FDA Received Date: 05/21/2025; 07/16/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 02/22/2011
• 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: METOPROLOL, AMLODIPINE, ZOCOR, PLAVIX, LOSARTAN.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 86 YR
• Patient Sex: Male
• Patient Weight: 82 KG