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

Model Number	PXT231218
Medical Device Problem Code	Insufficient Device Problem Information (3190)
Health Effect - Clinical Code	Clinical Endoleak (4843)
Date of Event	06/06/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
H6: code c19: a review of manufacturing records verified that the lots involved in this complaint met all pre-release specifications.H6: code b20: device remains implanted and therefore not available for direct analysis.H6: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to: endoleak.As gore was unable to determine which component was involved in this event the following gore® excluder® aaa endoprosthesis devices will be added to this report: 1.Catalogue: pxc121400 serial: (b)(6).Udi: (b)(4).2.Catalogue: pxl161207 serial: (b)(6).Udi: (b)(4).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 information was reported to gore: on (b)(6) 2010, this patient underwent endovascular treatment using gore® excluder® aaa endoprosthesis for an abdominal aortic aneurysm.On an unknown date, regular follow-up revealed common iliac artery dilatation and distal type i endoleak.Of the 3 devices that were implanted during initial procedure it is unknown which one was related to the distal type i endoleak.On (b)(6) 2023, the patient underwent reintervention.Reportedly, an additional stent graft was placed.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17262482
• Report Number: 2953161-2023-01184
• Device Sequence Number: 15161260
• Product Code: MIH
• UDI-Device Identifier: 00733132610129
• UDI-Public: 00733132610129
• 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: 2010
• 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): 07/05/2023

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: 02/28/2013
• Device Model Number: PXT231218
• Device Catalogue Number: PXT231218
• 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: 06/06/2023
• Initial Report FDA Received Date: 07/05/2023
• Date Device Manufactured: 03/09/2010
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Male