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

Model Number	RMT281416
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	02/03/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2013, the patient underwent endovascular treatment of an infrarenal abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On an unknown date, coiling was performed to treat a type ii endoleak at an unknown facility.On (b)(6), 2023, follow-up ct imaging revealed an endoleak of unknown origin.The gore representative became aware of the endoleak on february 6, 2023.After review of the ct imaging by the gore imaging sciences team, it was observed on comparison axial imaging that the aneurysm had enlarged from 69.3mm x 68.4mm in april, 2021 to 74.3mm x 75.4mm on the february, 2023 scans.On (b)(6) 2023, a reintervention was performed whereby an aortic extender component was implanted.The origin of the endoleak remains unknown.Reportedly a one month follow-up ct will be performed to monitor aneurysm growth.There were no further reported issues.The patient tolerated the procedure.
Additional Manufacturer Narrative
Patient weight: asked but unavailable other relevant history, including preexisting medical conditions: asked but unavailable concomitant medical products and therapy dates: asked but unavailable investigation findings: code c19 - the review of the manufacturing paperwork verified that the lots involved in this event met all pre-release specifications.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.Investigation findings: code c19 - the imaging evaluation, performed by a clinical imaging specialist, showed the following: two time-points available for evaluation - post-implantation cta dated 4/8/2021 and post-implantation cta dated 2/3/2023.With comparison axial imaging, no new endoleak can be identified.There is a change in the aneurysm size from 69.3mm x 68.4mm on 4/8/2021 imaging to 74.3mm x 75.4mm on 2/3/2023 imaging.Possible contrast is observed in the aneurysm sac, however, non-contrast or delayed-contrast series were not provided to confirm.Evaluation concludes probable type ii endoleak, of unknown origin, with available imaging.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu), potential device or procedure-related adverse events that may occur and/or require intervention include, but are not limited to, endoleak and aneurysm enlargement.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.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.

• 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 WOODY MOUNTAIN B/P; 3750 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: jenna lopez ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16492512
• Report Number: 2017233-2023-03778
• Device Sequence Number: 6592327
• Product Code: MIH
• UDI-Device Identifier: 00733132610723
• UDI-Public: 00733132610723
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2013
• 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): 03/06/2023

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: 02/28/2015
• Device Model Number: RMT281416
• Device Catalogue Number: RMT281416
• 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: 02/06/2023
• Initial Report FDA Received Date: 03/06/2023
• Date Device Manufactured: 03/12/2012
• 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: 80 YR
• Patient Sex: Male