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

Model Number	TGMR313110
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	No Known Impact Or Consequence To Patient (2692)
Date of Event	02/20/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The review of the manufacturing paperwork verified that this lot met all pre-release specification.According to the conformable gore® tag® thoracic endoprosthesis instructions for use state adverse events that may occur and/or require include, but are not limited to, endoleak.
Event or Problem Description
It was reported that the patient was treated for a thoracic aortic aneurysm on (b)(6) 2020 using a gore® tag® conformable thoracic stent graft with active control system.On (b)(6) 2020, follow up revealed a type ia endoleak.A reintervention is planned but currently not scheduled.It was reported that the device needs to be extended proximally.Images were returned for evaluation.The imaging evaluation stated:there are 2-time points available for evaluation: pre-implantation cta dated (b)(6) 2019 and post-implantation cta dated (b)(6) 2020.Pre-implantation imaging appears to show a pau in the proximal dta.Post-implantation cta appears to show: there appears to be contrast outside the proximal implanted device.There appears to be contrast outside the device posteriorly, also.Contrast outside the posterior device appears to communicate with an intercostal artery.Cannot confirm ante grade or retrograde flow in the intercostal artery.Probable type ia endoleak.

• Brand Name: AORTIC TAG THORACIC ENDOPROSTHESIS (CTAG WITH ACTIVE CONTROL)
• Common Device Name: SYSTEM, ENDOVASCULAR GRAFT, AORTIC ANEURYSM TREATMENT
• Manufacturer (Section D): W.L. GORE & ASSOCIATES; flagstaff AZ
• MDR Report Key: 9842543
• Report Number: 2017233-2020-00188
• Device Sequence Number: 11368014
• Product Code: MIH
• UDI-Device Identifier: 00733132646777
• UDI-Public: 00733132646777
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: P040043
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2020
• Reporter Type: Manufacturer
• Report Source: company representative
• Initial Reporter Occupation: Physician
• Type of Report: Initial
• Report Date (Section B): 02/20/2020

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: 06/26/2022
• Device Model Number: TGMR313110
• Device Catalogue Number: TGMR313110
• Device Lot Number: 21013820
• 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: 03/17/2020
• 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: Required Intervention
• Patient Age: 72 YR