MAUDE Adverse Event Report: W. L. GORE & ASSOCIATES, INC. GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM; SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGM343415J

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

Patient Problem Thromboembolism (2654)

Event Date 10/18/2022

Event Type  Injury  

Event Description

On (b)(6) 2022, a patient underwent endovascular treatment of an infected pararenal abdominal aortic aneurysm using two gore® tag® conformable thoracic stent grafts with active control system and a gore® dryseal flex introducer sheath.During treatment, reconstruction was also performed with a vascular graft sewn from the left common iliac artery to the superior mesenteric artery, left renal artery, and inferior mesenteric artery.The first gore® tag® device was implanted distally, then a second gore® tag® device (tgm343415j/ (b)(4) was implanted proximally.An intra-operative angiograph reportedly revealed no contrast at the celiac artery.Another angiograph with cannulation from the constrained vascular graft revealed contrast in the hepatic artery but not in the splenic artery.The patient tolerated the procedure.The physician stated that the cause for the lack of flow to the celiac artery was unknown.The physician commented that it could be due to a narrow root area, but he did not think the device covered the celiac artery.According to the report, an angiograph prior to device deployment at the celiac artery was not contrasted.It was reported the stent graft would not cover the celiac artery because the stent graft was implanted with clearly contrasted superior mesenteric artery alignment and vertebral body as a marker.There reportedly was a large amount of thrombus at the level of the abdominal bifurcation, which may have been moved by a wire or other maneuver.

Manufacturer Narrative

(b)(4).It should be noted that, per the gore® tag® conformable thoracic stent graft with active control system instructions for use, complications associated with the use of the gore® tag® conformable thoracic stent graft may include, but are not limited to, embolism (micro and macro) with transient or permanent ischemia, and branch vessel occlusion or obstruction.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® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• 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 WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: damon jackson ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 15770480
• MDR Text Key: 303408019
• Report Number: 2017233-2022-03464
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 11/10/2022

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: TGM343415J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/18/2022
• Initial Date FDA Received: 11/10/2022
• Date Device Manufactured: 04/28/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Sex: Male