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

Catalog Number PLC141400J

Device Problem Deformation Due to Compressive Stress (2889)

Patient Problem Stenosis (2263)

Event Date 12/11/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2023, this patient underwent an endovascular treatment of a right common iliac artery aneurysm using gore® excluder® aaa endoprosthesis.Two contralateral leg components, plc141400j and plc121200j, were placed at right side.The procedure was completed without any issue.On (b)(6) 2023, a stenosis due to compression in a part of the plc141400j was observed on a computed tomography imaging.Reportedly, the compression of the stent graft occurred at the site where the aortic was narrow.It was also reported that the patient was able to walk unassisted without any particular symptoms, and the ankle brachial index(abi) was nearly identical in the left and right legs.On (b)(6), 2023, a reintervention was performed, an additional stent graft was deployed from the same height as the contralateral leg component on the left side, and then ballooning was performed using kissing balloon technique.The procedure was completed upon confirming the patency of the stent graft.The patient tolerated the procedure.It was reported that the difference in radial force between the left and right stent grafts in the narrow lumen of the aorta caused the compression.There was no aneurysm enlargement reported.(b)(4) captured due to narrow lumen of the aorta.

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.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
• Type of Device: 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 SILICON VALLEY B/P; 2890 de la cruz blvd.; santa clara CA 95050
• Manufacturer Contact: monique nwanze ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18469459
• MDR Text Key: 332387855
• Report Number: 3013164176-2024-01953
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P020004
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 01/08/2024

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
• Device Catalogue Number: PLC141400J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/08/2024
• Date Device Manufactured: 09/06/2023
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 87 YR
• Patient Sex: Male