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

Catalog Number TGU404015J

Device Problem Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 01/11/2019

Event Type  Injury  

Manufacturer Narrative

According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu) states that complications associated with the use of the gore® tag® thoracic endoprosthesis may include but are not limited to improper component placement, branch vessel occlusion or obstruction, dissection, perforation, or rupture of the aortic vessel & surrounding vasculature, and neurologic damage, local or systemic (e.G., stroke, paraplegia, paraparesis).

Event Description

On (b)(6) 2019, this patient underwent endovascular procedure to treat a thoracic aortic aneurysm using conformable gore® tag® thoracic endoprostheses.It was reported a left subclavian - left common carotid artery bypass was performed, and the device was positioned for deployment at the origin of the left common carotid artery.After deployment of the device, it was reported the device appeared to cover (amount unknown) the left common carotid artery.An additional stent graft was reportedly implanted at the origin of the left common carotid artery and the patient tolerated the procedure.

Manufacturer Narrative

Code 213 - a review of the manufacturing paperwork verified this lot met all pre-release specifications.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Type of Device: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 8321902
• MDR Text Key: 135568202
• Report Number: 2017233-2019-00073
• Device Sequence Number: 1
• Product Code: MIH
• Combination Product (y/n): N
• PMA/PMN Number: P040043
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 02/08/2019

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
• Device Operator: Health Professional
• Device Expiration Date: 08/20/2021
• Device Catalogue Number: TGU404015J
• Device Lot Number: 18608153
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 02/08/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/08/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Required Intervention