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

Catalog Number	TGU373715
Medical Device Problem Code	Malposition of Device (2616)
Health Effect - Clinical Code	No Consequences Or Impact To Patient (2199)
Date of Event	09/09/2018
Type of Reportable Event	Serious Injury
Additional 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 also 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 or Problem Description
On (b)(6) 2018, 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 left subclavian artery (lsa).Reportedly, during deployment, the device ¿jumped¿ forward 3cm and completely covered the left subclavian artery and the left common carotid artery (lcc).It was reported the cause of the device jumping is unknown.It was reported the physician inflated a balloon inside of the device and pulled the device distally into the intended location, no longer covering any vessels.The procedure concluded without any further complications being reported.Final angiography showed complete exclusion of the aneurysm and the patient tolerated the procedure.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 7890853
• Report Number: 2017233-2018-00566
• Device Sequence Number: 1908503
• Product Code: MIH
• UDI-Device Identifier: 00733132618187
• UDI-Public: 00733132618187
• Combination Product (Y/N): N
• Initial Reporter State: NY
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 09/09/2018

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
• Operator of Device: Health Professional
• Device Expiration Date: 04/06/2020
• Device Catalogue Number: TGU373715
• Device Lot Number: 16237869
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/19/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Required Intervention