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	TGM212110
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/27/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
The following was reported to gore: on (b)(6) 2021, the patient presented with an aneurysm in the thoracic aorta and underwent treatment utilizing a gore® tag® conformable thoracic stent graft with active control system (ctag a/c).The physician advanced the ctag a/c device to the level of the left subclavian artery and deployed the graft successfully.Upon attempted removal of the delivery catheter, it was observed that the olive tip was caught on a stent strut.After multiple endovascular attempts to dislodge the olive tip, the stent started to pull away from the graft.The graft was ultimately pulled down into the infrarenal aorta and then explanted surgically.Once the graft was explanted and the aorta repaired another ctag a/c device was deployed successfully.The patient tolerated the procedure.
Additional Manufacturer Narrative
Added g3/g4, h1/h2 and h6 code: d0301.
Additional Manufacturer Narrative
Product evaluation: the gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: a stent apex was wedged between the olive and the catheter.A wedged apex can prevent the catheter from disengaging from the device post-deployment.The findings of the evaluation are consistent with the reported event description that the olive was caught on a stent, preventing the catheter from being removed following deployment.Based on the evaluation, the cause of the proximal apex being wedged between the catheter and olive is considered attributable to the manufacturing process.H3: device was returned and evaluated.

• 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: liam schultz ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 12837211
• Report Number: 2017233-2021-02547
• Device Sequence Number: 11850534
• Product Code: MIH
• UDI-Device Identifier: 00733132646890
• UDI-Public: 00733132646890
• Combination Product (Y/N): N
• Initial Reporter State: LA
• 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,Followup,Followup
• Report Date (Section B): 10/11/2022

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 05/18/2023
• Device Model Number: TGM212110
• Device Catalogue Number: TGM212110
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/27/2021
• Supplement Date Received by Manufacturer: 10/27/2021; 08/31/2022; 10/11/2022
• Initial Report FDA Received Date: 11/18/2021
• Supplement Report FDA Received Date: 01/04/2022; 08/31/2022; 10/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• 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: Hospitalization; Required Intervention
• Patient Sex: Male