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

Catalog Number	RLT281418
Medical Device Problem Code	Device Endoleak (4074)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	10/01/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
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 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.H.6.Type of investigation: code b15 - images were provided, and an imaging evaluation was performed.H.6.Investigation findings for imaging evaluation: code c19 - the imaging evaluation was performed by a clinical imaging specialist.One timepoint was available for evaluation: post-implantation cta dated (b)(6) 2024.The length from the left renal artery (lra) to the proximal circumferential device appeared to be 12.7mm, by centerline.Proximal aortic diameters just distal to the lra appeared to be 23.3mm, approximately 8mm distal to the lra appeared to be 26.4mm, and 15mm distal to the lra appeared to be 28.8mm.Proximal aortic diameters at the proximal circumferential device appeared to be 26.6mm, approximately 8mm distal to the proximal circumferential device appeared to be 28.5mm, and 15mm distal to the proximal circumferential device appeared to be 29.6mm.All diameters at these levels are greater than the implanted device treatment range.Reconstruction imaging showed contrast outside the implanted device at approximately 1.6cm distal to the proximal circumferential device.Probable proximal type i endoleak.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.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, the patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.On (b)(6) 2024, follow-up ct imaging was performed.A proximal type i endoleak was observed on the trunk-ipsilateral leg component.The physician reported the endoleak to the gore representative on (b)(6) 2024.On (b)(6) 2024, the patient underwent reintervention to treat the endoleak.A pla280300 gore® excluder® aaa aortic extender component was successfully implanted.The endoleak was deemed resolved, and the patient tolerated the reintervention.

• 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: 20612502
• Report Number: 3007284313-2024-03568
• Device Sequence Number: 7929726
• Product Code: MIH
• UDI-Device Identifier: 00733132622559
• UDI-Public: 00733132622559
• Combination Product (Y/N): N
• Initial Reporter State: GA
• 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): 11/05/2024

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: 01/17/2021
• Device Catalogue Number: RLT281418
• 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: 10/07/2024
• Initial Report FDA Received Date: 11/05/2024
• Date Device Manufactured: 01/18/2018
• 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: 81 YR
• Patient Sex: Male