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

Catalog Number	RMT231416
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	08/14/2024
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H.6.Type of investigation code b15: the imaging evaluation performed by a clinical imaging specialist showed the following: ¿ one time point available for evaluation: post-implantation cta dated (b)(6) 2024.¿ the length from the left renal artery (lowest renal) to the proximal circumferential device is ~8.8mm, be centerline.¿ aortic diameter just distal to the left renal artery is 22.3mm.¿ aortic diameter ~9mm distal to the left renal artery is 25.3mm.¿ there appears to be lack of proximal circumferential device apposition.¿ there is a small amount of contrast outside the proximal end of the implanted device.This finding is suggestive of a proximal type i endoleak.¿ comparison axial image series show: o there is bright contrast in a lumbar artery and another set of lumbar arteries distally on the arterial contrast image series.O contrast is visualized in the left posterior sac on delayed contrast image series at multiple levels.O only visualizing pooling contrast in the sac on the delayed contrast images is suggestive of type ii endoleak(s).H.6.Investigation findings code c20: the device remains implanted and is not available for analysis.H.6.Investigation findings code c19: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H.6.Investigation conclusion code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.Specifically, the ifu warns that 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
The following was reported to gore: on (b)(6) 2011, a patient was treated using gore® excluder® aaa endoprostheses.At that time, the aneurysmal sac reportedly measured about 6cm according to the patient.On an unknown date in 2018, a ct scan was taken measuring the aneurysmal sac at 7.8cm with a type two endoleak.On (b)(6) 2024, an endoleak was detected on a ct scan.The physician suspected this to be a type ii endoleak from the lumbar artery.The physician also noted dilation proximally, leading to a lack of device apposition.On (b)(6) 2024, a reintervention occurs to treat the suspected endoleak.The lumbar artery was coil embolized, and an aortic extender was placed proximally in the infrarenal neck.The patient tolerated the procedure.

• 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: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 20148048
• Report Number: 2017233-2024-05290
• Device Sequence Number: 8397480
• Product Code: MIH
• UDI-Device Identifier: 00733132610563
• UDI-Public: 00733132610563
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2011
• 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): 09/05/2024

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: 05/31/2014
• Device Catalogue Number: RMT231416
• 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: 08/14/2024
• Initial Report FDA Received Date: 09/05/2024
• Date Device Manufactured: 06/27/2011
• 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