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

Catalog Number	CXA360005
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Ruptured Aneurysm (4436)
Date of Event	06/25/2023
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Additional devices included on this report are as follows: catalog #cxa360005/ serial #(b)(6)/ udi #(b)(4), as the same device family.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.According to the gore® excluder® conformable aaa endoprosthesis instructions for use (ifu), 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, aneurysm enlargement, and aneurysm rupture.Additionally, the ifu states that the aortic extender endoprostheses are intended to be used after deployment of the gore® excluder® conformable aaa endoprosthesis.The gore® excluder® conformable aaa endoprosthesis is intended to exclude the aneurysm from the blood circulation in patients diagnosed with infrarenal abdominal aortic aneurysm disease and who have appropriate anatomy including, but not limited to, a proximal aortic neck angulation of less than or equal to 60°.The safety and effectiveness of the gore® excluder® conformable aaa endoprosthesis have not been evaluated in patient populations including, but not limited to, patient's with greater than 60° angulation of the proximal aortic neck.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) 2022, the patient underwent reintervention for a type i endoleak on an unknown device placed on an unknown date.Two gore® excluder® conformable aaa aortic extender components (cxa) were implanted proximally to treat the type i endoleak.On (b)(6) 2023, the patient presented emergently with a ruptured abdominal aortic aneurysm.It was reported that an unknown endoleak was observed, and appeared to be either a type i or type iii endoleak.The patient's aortic angle was reported as 90 degrees.It was reported that the patient was not a candidate for open procedure.Therefore, two additional cxa devices and two gore® excluder® aaa aortic extender components were implanted to treat the rupture.The rupture was successfully treated.There were no further reported issues.The patient tolerated the reintervention.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: 17378900
• Report Number: 3007284313-2023-02653
• Device Sequence Number: 15052710
• Product Code: MIH
• UDI-Device Identifier: 00733132650972
• UDI-Public: 00733132650972
• Combination Product (Y/N): N
• Initial Reporter State: MS
• Initial Reporter Country: US
• PMA/510(K) Number: P200030
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• 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): 07/24/2023

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: 02/26/2025
• Device Catalogue Number: CXA360005
• 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: 06/25/2023
• Initial Report FDA Received Date: 07/24/2023
• Date Device Manufactured: 02/28/2022
• 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: 84 YR
• Patient Sex: Male