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

Catalog Number	PXC141200
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aneurysm expansion (4597)
Date of Event	12/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
On (b)(6) 2012, this patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.On an unknown date, a ct imaging revealed aneurysm enlargement approximately 20mm, and a type ii endoleak from inferior mesenteric artery was suspected.In (b)(6) 2020, coil embolization was performed to treat the type ii endoleak.The patient tolerated the procedure.(this event was reported under (b)(4)).On an unknown date, a type iii endoleak (unknown whether component disconnection nor tear/disruption in graft material) and a type ii endoleak was suspected from an imaging.On (b)(6) 2020, re-intervention placing additional stent graft at the connection of the pxt261218 and pxc141200 was performed.The physician elected to monitor type ii endoleak, and no treatment was performed for type ii endoleak.The patient tolerated the procedure.(this event was reported under (b)(4)).On an unknown date, aneurysm enlargement was observed, inflammatory aneurysm and distal type i endoleak on the left side were suspected on the computed tomography angiography.On (b)(6) 2024, a re-intervention was performed, after the left internal iliac artery was embolized, an additional stent graft was placed down to the left external iliac artery.The patient tolerated the procedure.
Additional Manufacturer Narrative
H3: code "other" was selected as the medical device remains implanted.Return not possible.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.According to the gore® excluder® aaa endoprosthesis instructions for use (ifu) possible defects and adverse events include the following: 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 SUNNYVALE B/P; 1327 orleans drive; sunnyvale CA 94089
• Manufacturer Contact: hiroko sakamiya ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 21146585
• Report Number: 2953161-2025-01232
• Device Sequence Number: 9330405
• Product Code: MIH
• UDI-Device Identifier: 00733132609956
• UDI-Public: 00733132609956
• Combination Product (Y/N): N
• Initial Reporter Country: JA
• PMA/510(K) Number: P020004
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2012
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 01/14/2025

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: 09/30/2014
• Device Catalogue Number: PXC141200
• 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: 12/20/2024
• Initial Report FDA Received Date: 01/14/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/12/2011
• 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