MAUDE Adverse Event Report: W.L. GORE & ASSOCIATES AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL); SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT

Catalog Number TGM343415J

Device Problem Unintended Movement (3026)

Patient Problem Occlusion (1984)

Event Date 03/05/2020

Event Type  Injury  

Manufacturer Narrative

Event Description

On (b)(6) 2020, the patient underwent endovascular treatment of a thoracic aortic aneurysm using a conformable gore® tag® thoracic endoprosthesis with active control® (ctag ac).Patient anatomy included a bovine arch, where the left common carotid artery bifurcated from the innominate artery.A left subclavian artery to left common carotid artery bypass procedure was performed.The physician then attempted to implant the ctag ac just below the bifurcation of the innominate artery and the left common carotid artery.During operation of the secondary deployment handle, the ctag ac moved proximally approximately 3mm and the bovine arch was unintentionally partial covered by the ctag ac.It was reported to gore that there were no abnormalities noted during the deployment.The deployment was in accordance with the instructions for use.It was observed that the blood pressure of the left common carotid artery decreased.Therefore, as treatment, an epic® stent was implanted in the bovine arch.The blood pressure of the left common carotid artery recovered and the procedure was completed.The patient tolerated the procedure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: douglas rhodes ; 1500 n. 4th street; 9285263030
• MDR Report Key: 9898478
• MDR Text Key: 194884937
• Report Number: 2017233-2020-00218
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• Reporter Country Code: JA
• 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
• Report Date: 03/05/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/16/2022
• Device Catalogue Number: TGM343415J
• Device Lot Number: 21292697
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/17/2019
• 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): Other; Required Intervention
• Patient Age: 72 YR