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

Catalog Number	RLT281416
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Codes	Aneurysm expansion (4597); Clinical Endoleak (4843)
Date of Event	10/04/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #pla320400/ serial #(b)(6)./ udi # (b)(4) as a component of the same system.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: asked but unavailable h.6.Type of investigation: code b15 - images were provided, and an imaging evaluation will be performed.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.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) 2019, the patient underwent endovascular treatment of an abdominal aortic aneurysm (aaa) using gore® excluder® aaa endoprostheses.Dr.Yavorski was the implanting physician.A trunk-ipsilateral leg component and aortic extender component were implanted.On an unknown date, reported as spring of 2024, duplex showed aneurysm exclusion.The aneurysm sac measured 5.5cm.On (b)(6) 2024, dr.(b)(6) requested a review of a ct scan by the gore representative.The ct scan showed a separation of the aortic extender component and the trunk main body, resulting in a type iii endoleak into the aaa.The aneurysm sac measured greater that 8cm.A plan for reintervention is being evaluated by the geisinger vascular group.An endovascular intervention is being planned with an open surgical approach if the endovascular option fails.
Additional Manufacturer Narrative
B.3.Date of event: as the type iii endoleak was observed on follow-up ct imaging dated october 4, 2024, this date has been used as the updated date of event.H.6.Investigation findings for imaging evaluation: code c21 updated to code c0703.H.6.Investigation findings for imaging evaluation: code c0703 - images were returned and one time-point post-implantation cta dated (b)(6) 2024 was available for evaluation.An imaging evaluation was performed by a clinical imaging specialist and showed that the length from the right renal artery (rra) to the proximal aortic extender appeared to be 13.0mm by centerline.The aortic diameter just distal to the rra appeared to be 17.5mm.The diameter at the proximal aortic extender appeared to be 26.4mm.The aortic diameter within the area just distal to the rra and the proximal aortic extender appeared to be 25.4mm.The proximal gore® excluder aaa endoprosthesis was located 12cm distal to the rra by outer curve length, thereby confirming a type iii endoleak ¿ component separation.The maximum aortic diameter appeared to be ~8.1cm x 11.2cm.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.
Event or Problem Description
On (b)(6) 2025, the patient underwent reintervention whereby an endovascular gore® excluder® thoracoabdominal branch endoprosthesis (tambe) procedure was performed.The procedure was successful and the endoleak was resolved.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
B.5.Event description: additional information added.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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20680321
• Report Number: 3007284313-2024-03592
• Device Sequence Number: 18275012
• Product Code: MIH
• UDI-Device Identifier: 00733132622542
• UDI-Public: 00733132622542
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2019
• 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): 02/11/2025

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: 01/07/2022
• Device Catalogue Number: RLT281416
• 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: 10/15/2024
• Supplement Date Received by Manufacturer: Not provided; 01/17/2025
• Initial Report FDA Received Date: 11/14/2024
• Supplement Report FDA Received Date: 12/23/2024; 02/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/08/2019
• 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 Age: 77 YR
• Patient Sex: Female