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	TGMR373720
Medical Device Problem Code	Mechanical Problem (1384)
Health Effect - Clinical Code	Vascular Dissection (3160)
Date of Event	10/24/2021
Type of Reportable Event	Malfunction
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, the patient underwent endovascular treatment of an emergency thoracic dissection using a gore® tag® conformable thoracic stent graft with active control system.It was reported that the patient had tortuous anatomy.During advancement of the device onto the double curve lunderquist wire (.035x260), it was difficult to advance the device over the wire.During deployment, when the lock wire handle was released, the wires were not attached to the device.It is unknown if the wires were not attached to begin with or if they snapped during attempts to release and pull the handle.There was resistance when attempting to pull the handle and some force was used.The back up hatch was utilized, and the number three and number four wires were pulled.The device released from the delivery catheter.The device was successfully deployed and there was no injury to the patient.The patient tolerated the procedure.
Additional Manufacturer Narrative
H6: impact code.H6: code 213-the review of the manufacturing paperwork verified that this lot met all pre-release specifications.H6: investigation conclusion: addition the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed no device or images of the device were returned for evaluation.Based on the available information no conclusions can be made regarding the physician comments that there was reported tortuosity in the thoracic artery and any impact to the device.No potential root cause for the lockwire handle breaking could be confirmed since the device was not returned.

• 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: rachael chascsa ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12849068
• Report Number: 2017233-2021-02553
• Device Sequence Number: 4350975
• Product Code: MIH
• UDI-Device Identifier: 00733132646821
• UDI-Public: 00733132646821
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: PO40043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 12/15/2021

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: 11/07/2023
• Device Model Number: TGMR373720
• Device Catalogue Number: TGMR373720
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/25/2021
• Supplement Date Received by Manufacturer: 10/25/2021
• Initial Report FDA Received Date: 11/19/2021
• Supplement Report FDA Received Date: 12/15/2021
• Date Device Manufactured: 11/07/2020
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Patient Age: 73 YR
• Patient Sex: Female