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 TGMR373710

Device Problem Separation Failure (2547)

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

Event Date 01/03/2022

Event Type  malfunction  

Event Description

On (b)(6) 2022, the patient was treated for a thoracic aortic aneurysm.The physician used an elephant trunk technique using a gore® tag® conformable thoracic stent graft with active control system.The device was deployed, but was unable to be removed from the catheter - (1600-e, catheter events - other/unknown).The lock would not release, and the physician was unaware of the ability to use the escape hatch to resolve the issue, so he decided to use a different gore® tag® conformable thoracic stent graft with active control system.The patient tolerated the procedure.The device will be returned for evaluation.

Manufacturer Narrative

H.6.Investigation findings: code 3233 updated to code 213.H.6.Investigation conclusions: code 11 updated to code 4315.The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the stent graft was returned attached to the catheter and fully deployed.The lockwire was separated from the lockwire connector and lockwire handle.The lockwire was properly routed through the catheter, device, and into the curved olive.The angulation fibers were separated from the angulation handle but remained routed through the device and catheter.During testing for design verification, 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 an antegrade hybrid fashion may have contributed to the reported event.

Manufacturer Narrative

Codes for h6 were blank on previous report, although they were reported in h10.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13386103
• MDR Text Key: 291213453
• Report Number: 2017233-2022-02699
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132646807
• UDI-Public: 00733132646807
• 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: Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup,Followup
• Report Date: 04/22/2022

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
• Device Operator: Health Professional
• Device Model Number: TGMR373710
• Device Catalogue Number: TGMR373710
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 01/03/2022
• Initial Date FDA Received: 01/28/2022
• Supplement Dates Manufacturer Received: 02/10/2022; 02/10/2022
• Supplement Dates FDA Received: 02/10/2022; 04/22/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/31/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR
• Patient Sex: Female