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

Catalog Number	RLT311417
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/10/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Patient medication includes: amlodipine, b12-methyltetrahydrofolate, plavix, flonase, lisinopril, toprolol xl, prilosec, pravacho.H6: code c19-a review of the manufacturing records indicated the lot met all pre-release manufacturing specifications.As the device was not accessible, the product history review (phr) review was the extend of the investigation.No device problem was found per review of these records.H6: code c20 - the device remains implanted and, therefore, was not available for direct analysis by gore.It should be noted that, per the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and / or require intervention include, but are not limited to, endoleak.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) 2018 patient underwent an endovascular procedure to treat an abdominal aortic aneurysm utilizing gore® excluder® aaa endoprosthesisa (rlt311417 on the right and a plc181400 on the left).A prior cta in 2018 showed the limb was well apposed at that time and patient was asymptomatic.On (b)(6) 2023 a follow-up imaging showed a suspected type 2 endoleak involving a very low right accessory renal near the level of the aortic bifurcation with flow along the right sided limb.No treatment was planned at this time.On (b)(6) 2023, an angiogram was performed and showed a type 1b endoleak on the right side with antegrade filling of the right accessory renal artery.No aneurysm enlargement was noted.On (b)(6) 2023 reintervention surgery was performed.The physician chose to coil embolize the right accessory renal artery and then extended the right sided limb with an 18 mm excluder contralateral component.Fsa also reports there was 4-5 cm of room between the end of the rlt311417 component and the internal iliac artery, which aligned with initial device placement, and no migration was noted.Physician attributes this endoleak to disease progression.The patient tolerated the procedure without complication.

• 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: lillian espinoza ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18070167
• Report Number: 3007284313-2023-02874
• Device Sequence Number: 7684253
• Product Code: MIH
• UDI-Device Identifier: 00733132619092
• UDI-Public: 00733132619092
• 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
• 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): 11/03/2023

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: 03/26/2021
• Device Catalogue Number: RLT311417
• 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: 10/10/2023
• Initial Report FDA Received Date: 11/03/2023
• Date Device Manufactured: 03/27/2018
• 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: 78 YR
• Patient Sex: Male
• Patient Weight: 97 KG