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

Catalog Number TGU404015

Device Problem Unintended Movement (3026)

Patient Problem Aneurysm (1708)

Event Date 01/09/2019

Event Type  Injury  

Manufacturer Narrative

The review of the manufacturing paperwork verified that this lot met all pre-release specifications.According to the conformable gore® tag® thoracic endoprosthesis instructions for use (ifu), advance the endoprosthesis past the target location and pull back to desired position to release stored energy in the system.Additionally, while maintaining the exposed delivery catheter as straight as possible, deploy the endoprosthesis by pulling the deployment knob in a steady, continuous motion.The ifu states that complications associated with the use of the gore® tag® thoracic endoprosthesis may include, but is not limited to improper placement and branch vessel occlusion or obstruction.

Event Description

On (b)(6) 2019, the patient underwent treatment of a thoracic aortic aneurysm with a conformable gore® tag® thoracic endoprosthesis.It was reported the physician intended to implant the device just distal to the bovine arch.Reportedly, the device ¿jumped¿ forward approximately 2cm and partially covering the bovine arch.The cause of the device movement is reportedly unknown.It was reported the device was left in the patient and a bypass was performed to perfuse the bovine arch.The procedure concluded without any further complications being reported and the patient tolerated the procedure.

• 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
• Manufacturer (Section G): MEDICAL WOODY SPRINGS B/P; 3450 w. kiltie lane; flagstaff AZ 86005
• Manufacturer Contact: marcos ayala ; 1500 n. 4th street; 9285263030
• MDR Report Key: 8279261
• MDR Text Key: 134140885
• Report Number: 2017233-2019-00049
• Device Sequence Number: 1
• Product Code: MIH
• UDI-Device Identifier: 00733132618163
• UDI-Public: 00733132618163
• 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
• Report Date: 01/09/2019

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: 10/01/2021
• Device Catalogue Number: TGU404015
• Device Lot Number: 18794314
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/25/2019
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 10/02/2018
• 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
• Patient Age: 79 YR