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

Model Number	TGM282815
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Aortic Dissection (2491)
Date of Event	04/16/2020
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 gore® tag® conformable thoracic stent graft with active control system instructions for use (ifu), ¿adverse events that may occur and/or require intervention include, but are not limited to: improper component placement¿.
Event or Problem Description
On (b)(6) 2020, the patient was implanted with conformable gore® tag® thoracic endoprosthesis with active control system to treat a thoracic dissection with idiopathic myocardial hypertrophy.It was reported that after the physician deployed the thoracic endoprosthesis at the level of the carotid, the outer sleeve covered the carotid artery.The metal stent did not cross the ostium.The sleeve partially occluded the carotid.The physician chose to use a bare metal stent in the carotid artery so that blood flow could remain open.The patient tolerated the procedure.There was no anatomy anomalies.The physician did not use force or have any issues during implant.It is unknown why this occurred.

• 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: 10049451
• Report Number: 2017233-2020-00354
• Device Sequence Number: 3292667
• Product Code: MIH
• UDI-Device Identifier: 00733132646944
• UDI-Public: 00733132646944
• Combination Product (Y/N): N
• Initial Reporter State: FL
• 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): 04/16/2020

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: 07/22/2022
• Device Model Number: TGM282815
• Device Catalogue Number: TGM282815
• Device Lot Number: 20984573
• 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: 05/12/2020
• 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: Hospitalization; Required Intervention
• Patient Age: 39 YR