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

Device Problem Device Handling Problem (3265)

Patient Problem Vascular Dissection (3160)

Event Date 01/23/2022

Event Type  malfunction  

Manufacturer Narrative

(b)(4).

Event 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.

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
• 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: 13481161
• MDR Text Key: 290572760
• Report Number: 2017233-2022-02725
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• 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: 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
• Device Operator: Health Professional
• 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
• Initial Date Manufacturer Received: 01/24/2022
• Initial Date FDA Received: 02/08/2022
• Supplement Dates Manufacturer Received: 01/24/2022
• Supplement Dates FDA Received: 03/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/16/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Age: 61 YR
• Patient Sex: Female
• Patient Weight: 68 KG