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	TGM454515
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	12/21/2021
Type of Reportable Event	Malfunction
Event or Problem Description
On (b)(6) 2021, the patient was treated for an abdominal aortic aneurysm.A gore® tag® conformable thoracic stent graft with active control system was implanted.While attempting to deploy a second gore® tag® conformable thoracic stent graft with active control system.The lock pin wire tab that attaches to the handle broke off when the physician pulled back, the proximal end of the stent also pulled back and accordianed in on itself.The tab completely broke off the red handle.Fortunately, the first stent graft in combination with the second graft were able to successfully treat the aneurysm, and the patient tolerated the procedure.The delivery device will be returned for evaluation.
Additional Manufacturer Narrative
Code h6: type of investigation - code 4118 updated to code 3331 and code 10.Device was returned for evaluation and review of manufacturing records was completed.Code h6: investigation findings - code 3233 updated to code 213 as a result of evaluation findings and review of manufacturing records.Code h6: investigaton conclusions code 11 updated to code 4315 as a result of evaluation findings and review of manufacturing records.The gore® tag® conformable thoracic stent graft with active control system (cmds) device evaluation showed the following: the lockwire and lockwire connector were separated from the lockwire handle.The report of the lockwire handle breaking was confirmed during the device evaluation.The report of the proximal end of the stent graft pulling back could not be confirmed from the device evaluation.

• 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: greg rawlings ; 1505 n. fourth street; flagstaff, AZ 86004 ; 9285263030
• MDR Report Key: 13259085
• Report Number: 2017233-2022-02669
• Device Sequence Number: 4726959
• Product Code: MIH
• UDI-Device Identifier: 00733132646999
• UDI-Public: 00733132646999
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2021
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date (Section B): 01/27/2022

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
• Operator of Device: Health Professional
• Device Expiration Date: 01/06/2024
• Device Model Number: TGM454515
• Device Catalogue Number: TGM454515
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: 12/21/2021
• Supplement Date Received by Manufacturer: 12/21/2021
• Initial Report FDA Received Date: 01/14/2022
• Supplement Report FDA Received Date: 01/27/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 01/07/2021
• Is the Device Labeled for Single Use? (Y/N): Yes
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 52 YR
• Patient Sex: Male
• Patient Weight: 90 KG