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	TGMR313110
Medical Device Problem Code	Device Handling Problem (3265)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	01/23/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
(b)(4).
Event or Problem Description
On (b)(6) 2022, this patient underwent treatment for a type a dissection and hemiarch using a frozen elephant trunk procedure and a gore® tag® conformable thoracic stent graft with active control system.It was reported that the secondary deployment fiber snapped as the grey handle was being removed from the delivery system.The physician attempted to pull and cut fiber 2, wire 3, and fiber 4 but they all snapped in the hatch due to high resistance within the grey catheter.The physician opened the access hatch of the backup deployment mechanism and manually pulled and cut the deployment fibers/lockwire by direct visualization and manual manipulation at the distal edge of the stent graft and delivery catheter.The procedure was concluded with good results.The patient tolerated the procedure with deployment of the device in the intended location.
Additional Manufacturer Narrative
The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: it appears that the full length of the secondary deployment (sdl) was returned and there is no indication of the sdl breaking during deployment.The lockwire was separated from the lockwire handle and returned in two pieces.The returned lockwire was properly routed through the catheter.The angulation fiber handle was returned without the angulation fibers or connector.During testing for design verification, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.Based on the lockwire being separated from the lockwire handle, this suggests that there was likely difficulty when initially removing the lockwire.There is potential that off-label use in an antegrade hybrid fashion may have contributed to the reported event.Based on the event description and device evaluation, no manufacturing deficiencies could be confirmed so no capa request is required.Events will continue to be monitored by gore.

• 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: laura crawford ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13481161
• Report Number: 2017233-2022-02725
• Device Sequence Number: 5462221
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 03/15/2022

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 Expiration Date: 08/14/2024
• Device Model Number: TGMR313110
• Device Catalogue Number: TGMR313110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/27/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/24/2022
• Supplement Date Received by Manufacturer: 01/24/2022
• Initial Report FDA Received Date: 02/08/2022
• Supplement Report FDA Received Date: 03/16/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 68 KG