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

Catalog Number TGU404020J

Device Problem Unintended Movement (3026)

Patient Problem Vascular Dissection (3160)

Event Date 04/17/2019

Event Type  Injury  

Manufacturer Narrative

According to the instructions for use (ifu) for the gore® tag® thoracic endoprosthesis; adverse events that may occur include, but are not limited to include: endoprosthesis: improper component placement; component migration; endoleak.

Event Description

On (b)(6) 2019, this patient underwent endovascular treatment for a stanford type b dissection and was implanted with two conformable gore tag® thoracic endoprostheses (ctag).During deployment of the first endoprosthesis which whose intended location was just distal to the brachiocephalic artery, the device moved distally and landed just below the left common carotid artery (lcca) reportedly due to the angulation of the patient's aortic arch.A second ctag endoprosthesis was then advanced and deployed to extend coverage of the first device distally.Intraprocedural angiography visualized a distal type i endoleak.Angioplasty was performed and reduced the endoleak but did not fully resolve it.The patient tolerated the procedure.On unknown date ((b)(6) or (b)(6) 2019), follow-up imaging identified a proximal type i endoleak, and showed a distal type i endoleak persisted.On (b)(6) 2019, the patient underwent reintervention and an additional ctag endoprosthesis was implanted just distal to the brachiceplalic artery and extended coverage within the most proximal ctag originally implanted.The proximal endoleak was resolved.Additional angioplasty of the distal end was also performed at this time resolved the distal type i endoleak.The patient tolerated the procedure.

Manufacturer Narrative

B3: corrected/additional information.

• 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: 8616115
• MDR Text Key: 145252082
• Report Number: 2017233-2019-00354
• 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: 06/03/2019

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: 11/30/2021
• Device Catalogue Number: TGU404020J
• Device Lot Number: 20085660
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 05/16/2019
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 06/03/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Hospitalization; Other; Required Intervention
• Patient Age: 67 YR