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

Catalog Number	RLT351414
Medical Device Problem Codes	Insufficient Flow or Under Infusion (2182); Positioning Problem (3009)
Health Effect - Clinical Codes	Obstruction/Occlusion (2422); Renal Impairment (4499); Reduced Blood Flow (4598)
Date of Event	10/21/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) state ¿adverse events that may occur and/or require intervention include, but are not limited to improper endoprosthesis component placement, renal complications (e.G., artery occlusion, contrast toxicity, insufficiency, failure) and occlusion of device or native vessel.¿ 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
The following was reported to gore: on (b)(6) 2023, the patient underwent an emergent endovascular zone 8 renals procedure to treat an aneurysm rupture utilizing a gore® excluder® aaa endoprosthesis (rlt351414, plc231200, plc231000, plc 141400 and plc21000).Reportedly, during the emergent procedure the physician had already deployed the trunk ipsilateral leg c3 by the time the field sales associate (fsa) arrived and there was difficultly cannulating the contralateral leg but they were able to successfully cannulate and deploy the device after rotating the graft without further issues.Physician stated that he purposely covered the renal arteries with trunk ipsilateral leg c3 in order to have a proper seal and stop the aortic rupture bleeding and all devices deployed without any issues.Patient tolerated the procedure but patient condition was not good and patient status at this time is unknown and further information is being sought.Additional information received on october 24, 2024: patient is doing okay after the procedure and per the latest ct scans, the aneurysm rupture is contained but there are kidney issues due to both the renal arteries coverage as there is partial blood flow and test results show elevated creatinine levels.The physician plans to intervene in the near future by adding a bare metal stent to make the blood flow more efficient and patient is currently being monitored.

• 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18097023
• Report Number: 3007284313-2023-02879
• Device Sequence Number: 6613608
• Product Code: MIH
• UDI-Device Identifier: 00733132618477
• UDI-Public: 00733132618477
• Combination Product (Y/N): N
• Initial Reporter State: ND
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 11/08/2023

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: 02/07/2026
• Device Catalogue Number: RLT351414
• 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: 10/21/2023
• Initial Report FDA Received Date: 11/08/2023
• Date Device Manufactured: 02/09/2023
• 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; Other; Hospitalization
• Patient Age: 67 YR
• Patient Sex: Male