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

Catalog Number CXA230005

Device Problem Fluid/Blood Leak (1250)

Patient Problem Ulcer (2274)

Event Date 07/14/2023

Event Type  Injury  

Manufacturer Narrative

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 Description

On (b)(6) 2022, this patient underwent endovascular treatment for an abdominal aortic ulceration and two gore® excluder® aortic extender components were implanted.The patient tolerated the procedure.Follow-up computed tomography on an unknown date showed continued filling of the ulceration.On (b)(6) 2023, the patient underwent reintervention for a suspected type iii endoleak due to insufficient overlap of the two extender components.The physician did not state there was a disconnect of the two components, just an insufficient overlap zone.Additionally, one of the devices appears to sort of bird beak out into the ulceration which contributed to the persistent filling.A gore® tag® conformable thoracic stent graft with active control system was implanted to reline the gore® excluder® aortic extender components.The patient tolerated the procedure.

Manufacturer Narrative

The imaging evaluation performed by a clinical imaging specialist showed the following: one time-point available for evaluation: post-implantation cta dated (b)(6) 2023.Images show 2 aortic extenders implanted in the abdominal aorta.The length of the device overlap is ~22mm.There is contrast in the sac at the level of the distal 2nd aortic extender.Just distal to the pooling of contrast there is a patent lumbar artery.Cannot confirm ante grade or retrograde flow.Endoleak of unknown origin.The instructions for use (ifu) for the gore® excluder® aaa endoprosthesis states;; adverse events that may occur and / or require intervention include but are not limited to: endoleak.

Manufacturer Narrative

Corrected information: manufacturing site number and address: 3007284313 medical phoenix 2 b/p 32470 n.North valley parkway phoenix az 85085.

• Brand Name: GORE® EXCLUDER® CONFORMABLE 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 17477153
• MDR Text Key: 320583351
• Report Number: 3013164176-2023-01787
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132650934
• UDI-Public: 00733132650934
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P200030
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 11/02/2023

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
• Device Operator: Health Professional
• Device Catalogue Number: CXA230005
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 08/07/2023
• Supplement Dates Manufacturer Received: 07/14/2023; 07/14/2023
• Supplement Dates FDA Received: 11/01/2023; 11/02/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2021
• 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): Other; Required Intervention; Hospitalization
• Patient Age: 65 YR
• Patient Sex: Male
• Patient Weight: 124 KG