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

Catalog Number RLT261218J

Device Problem Patient-Device Incompatibility (2682)

Event Date 11/27/2023

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.H.6.Investigation conclusions code d1001: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with type ii endoleaks and are instructed to consider the risks and benefits discussed in the ifu for each patient before using the devices.H.6.Investigation conclusions code d12: specifically, the ifu warns that adverse events that may occur and / or require intervention include, but are not limited to endoleak.

Event Description

The following information was reported to gore: on (b)(6) 2020, a patient underwent endovascular treatment of an abdominal aortic aneurysm using gore® excluder® aaa endoprostheses.Two contralateral leg components were implanted into the right common iliac artery.Details of the position of the two contralateral leg components was unknown.No follow up was performed.On an unknown date in november 2023, a computed tomography angiography revealed a proximal type i endoleak, a type ii endoleak, an aneurismal change of the right internal iliac artery, and dilation of the right common iliac artery.On november 27, 2023, a reintervention was performed to embolize an inferior mesenteric artery, the origin of the type ii endoleak.On december 4, 2023, a reintervention was performed for the proximal type i endoleak and the right leg.An aortic extender was implanted to extend proximally.No endoleak was confirmed.The patient tolerated the procedure.The physician stated that the postoperative course was unknown because there was no follow-up for 3 years after the initial treatment.

• 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 PHOENIX 2 B/P; 32470 n. north valley parkway; phoenix AZ 85085
• Manufacturer Contact: bryce wargin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18415713
• MDR Text Key: 331576002
• Report Number: 3007284313-2023-02981
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 12/28/2023

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 Expiration Date: 12/04/2020
• Device Catalogue Number: RLT261218J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/04/2023
• Initial Date FDA Received: 12/28/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/05/2017
• 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: 74 YR
• Patient Sex: Male