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	Failure to Disconnect (2541)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	04/02/2022
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The following patient information was requested but was not made available by the physician/treating facility: name, date of birth, weight, comorbidities, and medications (b)(4).
Event or Problem Description
As reported, on (b)(6) 2022 the patient was admitted for treatment of an emergency type a dissection.It was noted that the there was also a type b dissection present and the physician decided to treat this as well once the patient became symptomatic.A frozen elephant trunk procedure was conducted using a gore® tag® conformable thoracic stent graft with active control system (tgmr313110) was chosen.Deployment was successful for the first two stages of deployment with the gore® tag® conformable thoracic stent graft with active control system.When the physician was proceeding with release of the device from the catheter a large pop was heard and it was observed that there was no lockwire connected to the handle.As reported, the backup deployment access hatch was opened and the lockwire was not observed.Given the way the device was deployed, the physician was able to pull the graft and delivery system out and placed another in its place.The second endoprosthesis and deployed normally.As reported, the patient is doing fine.
Additional Manufacturer Narrative
G3/g4 date received by manufacturer 13-may-2022: evaluation activities were completed in full on this day.H6: code 4315, cause not established - the device was returned for engineering evaluation: the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the stent graft was fully deployed which aligns with the report that the first two stages of deployment were successful.The lockwire was disconnected from the lockwire handle.The lockwire was identified in the backup deployment hatch.The lockwire was properly routed through the catheter, device, and into the curved olive.The angulation fiber loops, which connect the fibers to the lockwire, remained wrapped around the lockwire.The remainder of the angulation fibers were not returned.The report of the lockwire separating from the lockwire connector was confirmed during the device evaluation.During testing for design 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.Based on the event description and device evaluation, per md145952 rev.23, no manufacturing deficiencies could be confirmed.According to the product instructions for use (ifu), the gore® tag® conformable thoracic stent graft with active control system is intended for endovascular repair of all lesions of the descending thoracic aorta.The device is not indicated for use in open frozen elephant trunk procedures.B1: malfunction should have been indicated instead of serious injury in original report.This field has been updated to indicate malfunction.

• 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: 14189926
• Report Number: 2017233-2022-02877
• Device Sequence Number: 11836649
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2022
• 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): 05/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/08/2024
• Device Model Number: TGMR313110
• Device Catalogue Number: TGMR313110
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/12/2022
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 04/06/2022
• Supplement Date Received by Manufacturer: 05/13/2022
• Initial Report FDA Received Date: 04/22/2022
• Supplement Report FDA Received Date: 05/19/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 03/10/2021
• 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: Other; Hospitalization
• Patient Sex: Unknown