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 TGM343420J

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

Patient Problem Embolism/Embolus (4438)

Event Date 02/22/2024

Event Type  Death  

Manufacturer Narrative

H3: code "other" was selected as the medical device did not return from the facility.H6: a review of the manufacturing records for the device verified that the lot met all pre-release specifications.H6: code d12: according to the gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), adverse events that may occur and/or require intervention include, but are not limited to : death, embolism (micro and macro) with transient or permanent ischemia 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

The following information was reported to gore: on (b)(6) 2024, this patient underwent endovascular treatment for a thoracic aortic aneurysm using gore® tag® conformable thoracic stent graft with active control system, and gore® dryseal flex introducer sheath as an accessory.Non-gore stent graft was implanted in the proximal side and ctag was placed in the distal side.Blood flow seemed to be very slow in the distal side of the device via contrast imaging.Blood flow was observed to the abdominal branch vessels, but it was also slow.The descending aorta had severe shaggy aorta, which led to suspicion of thrombus dispersal.No additional treatment was performed on the abdominal branch vessels.Mep (motor evoked potential) monitoring was performed before removing the sheath, which confirmed the loss of potential.There was a concern about paraplegia.Blood flow in the left lower limb could not be confirmed by ultrasound after removing the sheath.The patient was deemed to have embolization and ischemia of the left lower limb and was transferred to a thrombectomy.The patient tolerated the procedure.It is currently unknown whether the patient subsequently developed paraplegia.Physician¿s comment: ¿ this patient originally had shaggy aorta.I kept pushing and pulling the catheter during the delivery of a non-gore stent graft, and this movement may have affected the blood flow.Mep was performed only once and i am not sure when the loss of potential occurred.¿ additional information: the patient was expired the day after the procedure, (b)(6) 2024.It was reported that the thromboembolism likely led to multiple organ failure.Detailed information of the cause of death or autopsy was not obtained from the physician.No information was obtained on the details of the procedure after thrombectomy.The development of paraplegia was not clearly reported from the physician.

• 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: rie kaba ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 18872233
• MDR Text Key: 337290136
• Report Number: 2017233-2024-04693
• 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: Foreign,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial
• Report Date: 03/11/2024

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: TGM343420J
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/22/2024
• Initial Date FDA Received: 03/10/2024
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 11/21/2023
• 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): Death; Required Intervention
• Patient Age: 82 YR
• Patient Sex: Male