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	TGM282815
Medical Device Problem Codes	Break (1069); Physical Resistance/Sticking (4012)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/02/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, the patient was treated for a dissection of the ascending aorta.An open procedure was performed, and the physician performed a frozen elephant trunk procedure.He deployed a gore® tag® conformable thoracic stent graft with active control system, but when he tried to use the red knob to complete the third step of the deployment, he found it difficult to move, and ended up breaking the deployment line.The physician did not remember how to cut the line using the escape hatch, so ended up removing the device.A second device was successfully implanted.The patient tolerated the procedure.The device was discarded at the facility, as the patient was hiv positive, and the hospital did not wish to release the contaminated device.
Additional Manufacturer Narrative
H6: code 4115 - device discarded at facility.H6: code 3221 - due to device being discarded at facility, device could not be evaluated.H6: code 4315 - due to device being discarded at facility, no cause for the malfunction could be determined.The gore® tag® conformable thoracic stent graft with active control system (cmds) device was not returned for evaluation.During testing for design validation, process qualification, and ongoing quality control testing, devices are tested in anatomical models representative of cmds indicated use.Based on the evaluation, the reported difficulty and inability to remove the lockwire could not be confirmed.There is potential that off-label use in a frozen elephant trunk fashion may have contributed to the reported event.

• 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
• MDR Report Key: 12226390
• Report Number: 2017233-2021-02198
• Device Sequence Number: 1377333
• Product Code: MIH
• UDI-Device Identifier: 00733132646944
• UDI-Public: 00733132646944
• Combination Product (Y/N): N
• Initial Reporter State: SC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Device Explanted Year: 2021
• Reporter Type: Manufacturer
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 08/19/2021

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: 12/09/2022
• Device Model Number: TGM282815
• Device Catalogue Number: TGM282815
• Was Device Available for Evaluation?: No
• Initial Date Received by Manufacturer: 07/02/2021
• Supplement Date Received by Manufacturer: 07/02/2021
• Initial Report FDA Received Date: 07/27/2021
• Supplement Report FDA Received Date: 08/19/2021
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 38 YR