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

Model Number TGM282810

Device Problem Device Handling Problem (3265)

Patient Problem Vascular Dissection (3160)

Event Date 03/23/2023

Event Type  malfunction  

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) 2023, this patient underwent open/endovascular treatment for a dissection.It was reported that a gore® tag® conformable thoracic stent graft with active control system was advanced antegrade through the chest within a frozen elephant trunk.It was reported that the first stage of deployment ¿misfired¿.It was reported that the physician then pulled the primary deployment handle to get the device to 50% deployment but the physician did not feel the device deployed correctly or fully and the inner curve appeared pulled down.It is unknown if the device was advanced over a guidewire or not.The device was removed from the patient and the procedure was completed with another manufacturers device.The patient tolerated the procedure.The device is being returned to gore for evaluation, the results will be provided with the submission of a supplemental medwatch.

Manufacturer Narrative

H6: d12: according to the instructions for use (ifu), complications associated with the use of the gore® tag® conformable thoracic stent graft may include but are not limited to: stent graft: incomplete deployment.The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the device was returned fully deployed with signs of angulation despite the report of incorrect or incomplete primary deployment with the inner curve pulled down.The angulation fibers were separated from the angulation handle but remained routed through the device and catheter.During testing for design validation, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.Based on the evaluation, the reported misfiring of primary deployment and the device not deploying correctly could not be confirmed.There is potential that deploying the device outside of the indicated use may have contributed to the reported event.Based on the event description and device evaluation no manufacturing deficiencies could be confirmed.Events will continue to be monitored by gore.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 16637613
• MDR Text Key: 312421395
• Report Number: 2017233-2023-03826
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646937
• UDI-Public: 00733132646937
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 04/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: TGM282810
• Device Catalogue Number: TGM282810
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 03/23/2023
• Initial Date FDA Received: 03/29/2023
• Supplement Dates Manufacturer Received: 03/23/2023
• Supplement Dates FDA Received: 04/25/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/15/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 64 YR
• Patient Sex: Male