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

Device Problem Separation Failure (2547)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 10/27/2021

Event Type  Injury  

Event 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.

Manufacturer Narrative

Added g3/g4, h1/h2 and h6 code: d0301.

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
• Type of Device: 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
• MDR Text Key: 280970390
• Report Number: 2017233-2021-02547
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646890
• UDI-Public: 00733132646890
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 10/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/18/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 10/11/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/18/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Sex: Male