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

Model Number	RLT261418
Medical Device Problem Codes	Patient-Device Incompatibility (2682); Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	05/16/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2018, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2023, the physician informed the gore representative that an intervention would be performed to treat a proximal type i endoleak and a possible distal type i endoleak (indeterminate endoleak was observed).It was also reported that the aneurysm had grown by an estimated 1.5cm.On (b)(6) 2023, the reintervention was attempted.However, it was reported that access was unattainable as the access vessel was of poor quality.Therefore, the surgeon elected to abort the case.No reintervention was performed and, due to the patient¿s dnr status and the condition of the access vessels, there are no plans for another reintervention attempt.
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #pxc141400/ serial #: (b)(6)/udi #: (b)(4) as the same device family.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.Investigation conclusions: code d15 - this complaint was initiated based on information received from the field.The information reported in the complaint does not reasonably suggest that a potential device malfunction has occurred.Neither clinical images enabling direct assessment of product performance nor the product itself were returned for evaluation.Additional information was requested from the field; however, no attributable cause or contributing factors to the adverse event could be identified.Therefore, the cause of the reported adverse event could not be determined with the available information.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.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 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: 17131810
• Report Number: 3007284313-2023-02554
• Device Sequence Number: 20447545
• Product Code: MIH
• UDI-Device Identifier: 00733132622474
• UDI-Public: 00733132622474
• 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: 2018
• 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): 06/14/2023

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: 09/12/2020
• Device Model Number: RLT261418
• Device Catalogue Number: RLT261418
• 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: 05/16/2023
• Initial Report FDA Received Date: 06/14/2023
• Date Device Manufactured: 09/13/2017
• 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: 81 YR
• Patient Sex: Male