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	TGM454520
Medical Device Problem Code	Insufficient Flow or Under Infusion (2182)
Health Effect - Clinical Code	Reduced Blood Flow (4598)
Date of Event	06/18/2024
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2024, the patient underwent an open frozen elephant trunk procedure to treat an ascending aortic aneurysm utilizing a gore® tag® conformable thoracic stent graft with active control system (ctagac).Reportedly, a terumo stent graft was used along with the ctagac by doing anastomosis of the two grafts.The ctagac was deployed antegrade into the aorta and the first two deployments came off successfully but the 3rd deployment step did not deploy properly as the lockwire broke from the handle.As the handle came off (broke) and the deployment line would not deploy as the lockwire was not released yet, so the physician had to cut the line with scissors and pull to release the lockwire line (did not use the backup hatch for deployment).At the 4th deployment step, the wire got hung and it would not deploy, hence, physician had to go back to step 3 and cut the constraining wire then back to step 4 of deployment and finish pulling the string to complete the deployment and off the catheter.There was lot of tension felt during the 3rd and 4th deployment steps (catheter was curved and guidewire was not used by physician but was recommended by the field sales associate).Patient was closed up and angiogram was done when it was noted that there wasn't efficient blood flow and the graft wasn't fully opened as the distal end of the graft was curled (turned towards the side) in the aneurysm sac.Physician decided to add another ctagac with distal extension from the femoral access by putting up a large sheath and ballooned with a tri-lobe balloon, after which the device was fully opened up with efficient blood flow and no endoleaks were noted.There were no anatomical challenges, patient was in circulatory arrest during procedure and procedure completed successfully and patient is doing well.
Additional 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.
Additional Manufacturer Narrative
Added g3/g4, h1/h2, h6.H6: code c19 - a review of the manufacturing records indicated the lot met all pre-release specifications.H6: code b20 -the device remains implanted and was therefore not available for engineering evaluation by gore.Engineering evaluation summary: the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the stent graft was not returned.The primary and secondary deployment lines as well as the lockwire and angulation fibers were returned.All the handles were returned.The lockwire was still routed through both skives, the catheter transition, and the olive¿although it was cut between the olive and leading skive as well as between the distal skive and transition.It was not routed through the stent graft.The lockwire was seen in the access hatch and in the white handle component.The lockwire was not cut in the access hatch.The lockwire ferrule was broken out of the red handle piece.Based on the evaluation, the reported difficulty and inability to remove the lockwire was not confirmed, and no root cause could be identified.The angulation fiber lines were not routed through the stent graft or transition.They were still routed through part of the catheter, were seen in the access hatch, and were still connected to their handle.During testing for design validation and verification, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.There is potential that off-label use in an antegrade hybrid fashion may have contributed to the reported event.

• Brand Name: GORE® TAG® CONFORMABLE THORACIC STENT GRAFT WITH ACTIVE CONTROL SYSTEM
• Common Device Name: 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: jaskaran parhar ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 19740958
• Report Number: 2017233-2024-05108
• Device Sequence Number: 15397750
• Product Code: MIH
• UDI-Device Identifier: 00733132647002
• UDI-Public: 00733132647002
• Combination Product (Y/N): N
• Initial Reporter State: AR
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/15/2024

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
• Operator of Device: Health Professional
• Device Catalogue Number: TGM454520
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/18/2024
• Supplement Date Received by Manufacturer: 08/15/2024
• Initial Report FDA Received Date: 07/15/2024
• Supplement Report FDA Received Date: 08/15/2024
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/11/2024
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other; Required Intervention
• Patient Age: 77 YR
• Patient Sex: Male