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

Catalog Number RLT261414J

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abscess (1690); Myocarditis (2470); Pseudoaneurysm (2605)

Event Date 11/01/2023

Event Type  Injury  

Event Description

The following information was reported to gore: on (b)(6) 2021, this patient underwent an endovascular treatment for an abdominal aortic aneurysm using gore® excluder® aaa endoprosthesis.A trunk - ipsilateral leg endoprosthesis and a iliac extender endoprosthesis were implanted on the left side, and a contralateral leg endoprosthesis was implanted on the right side.On an unknown date, stent graft infection was identified.In (b)(6) 2023 (date unknown), the patient underwent open surgery.Except the trunk portion of the trunk - ipsilateral leg endoprosthesis, all stent grafts were removed, and it was converted to y-graft replacement.Reportedly, proximal and distal landing zones were clean, and pus was accumulating in the aneurysm wall.In (b)(6) 2023 (date unknown), a pseudoaneurysm formed at the proximal end (left renal artery side) of the remaining trunk portion of the trunk - ipsilateral leg endoprosthesis.It is being monitored.The physician reportedly stated as follows: around the end of 2021 (about 2 months after the initial procedure), a cholangiocarcinoma resection was performed.The stent graft infection was most likely caused by this surgery.The pseudoaneurysm may have been caused by a clamping forceps that was used on the trunk - ipsilateral leg endoprosthesis during y-graft replacement.However, in my experience, a pseudoaneurysm did not form after similar procedures with past other procedures.

Manufacturer Narrative

H.6.: code c19: a review of manufacturing records verified that the lot involved in this complaint met all pre-release specifications.H.6.: code b20: device was discarded at medical facility and therefore not available for direct analysis.H.6.: code d12: according to the gore® excluder® aaa endoprosthesis instructions for use (ifu), users are made aware of the risks associated with the use of the device and the adverse events that may occur and or require intervention include, but are not limited to: infection, wound complications, arterial or venous thrombosis and/or pseudoaneurysm.As gore was unable to determine which device/device component is involved in this reportable adverse event, the following additional devices will be identified in this report: device name: gore® excluder® aaa endoprosthesis, lot # 20059739, catalog # plc181200j, udi # (b)(4).Device name: gore® excluder® aaa endoprosthesis, lot # 20059743, catalog # pll161207j, 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.

• 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: kathryn irwin ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18307719
• MDR Text Key: 330228779
• Report Number: 3007284313-2023-02937
• 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: 12/11/2023

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 Expiration Date: 01/31/2024
• Device Catalogue Number: RLT261414J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 11/16/2023
• Initial Date FDA Received: 12/11/2023
• Date Device Manufactured: 02/01/2021
• 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
• Patient Age: 80 YR
• Patient Sex: Male