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	Separation Problem (4043)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	01/25/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Insufficient information, used as no response was able to be obtained from the physician on the patient information, status, or procedure following the described event.Modified surgical procedure, used to address that the procedure in process would have had to be modified due to the removal of the device.Separation problem, used to capture the reported issue with device separation from the catheter.No device problem found, used to document that a review of the manufacturing records for the device verified that the lot met pre-release specifications.
Event or Problem Description
On (b)(6) 2022 the patient was undergoing a frozen elephant trunk procedure using a gore® tag® conformable thoracic stent graft with active control system.As reported, the physician attempted to deploy the device but the nose cone would not become detached from the graft.The physician was therefore unable to use the device.Additional information was requested regarding the event but was not provided.
Additional Manufacturer Narrative
A1: no patient specific details have been provided.G3/g4: engineering evaluation of returned device was completed on march 7th, 2022.H6: 4315, cause not established the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the graft material was partially torn distally of the distal end lockwire routing hole.The stent graft was not physically attached to the olive per the event description.The lockwire was not attached to the lock wire handle, but it was present in the deployment line access hatch of the handle and the trailing transition of the catheter.The lockwire was properly routed through the endoprosthesis and into the curved olive.The angulation fibers were separated from the angulation handle and cut at the device but appeared routed through the catheter.Based on the event description and device evaluation no manufacturing deficiencies could be confirmed.B2 the following were previously checked but should not have been as there was no patient information or follow up provided from the physician upon request.Required intervention to prevent permanent impairment or damage.Other serious important events.

• 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: breanna cox ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13528302
• Report Number: 2017233-2022-02743
• Device Sequence Number: 19890575
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• Combination Product (Y/N): N
• Initial Reporter State: GA
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• 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): 04/18/2022

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: 07/06/2024
• Device Model Number: TGMR313110
• Device Catalogue Number: TGMR313110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/01/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/26/2022
• Supplement Date Received by Manufacturer: 03/07/2022
• Initial Report FDA Received Date: 02/14/2022
• Supplement Report FDA Received Date: 04/18/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 07/08/2021
• 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: Required Intervention; Hospitalization; Other
• Patient Sex: Unknown