GORE TAG Thoracic Branch Endoprosthesis Side Branch Component Catalog Numbers (by Region) United States (includes Puerto Rico) and Canada: TSB080806A, TSB081006A, TSB081206A, TSB081506A, TSB081706A, TSB121506A, TSB121706A, TSB122006A EMEA Countries, Australia, New Zealand: TSB080806E, TSB081006E, TSB081206E, TSB081506E, TSB081706E, TSB121506E, TSB121706E, TSB122006E Japan: TSB080806J, TSB081006J, TSB081206J, TSB081506J, TSB081706J, TSB121506J, TSB121706J, TSB122006J China and Taiwan: TSB080806W, TSB081006W, TSB081206W, TSB081506W, TSB081706W, TSB121506W, TSB121706W, TSB122006W The GORE TAG Thoracic Branch Endoprosthesis is indicated for endovascular repair of lesions of the aortic arch and descending thoracic aorta, while maintaining flow into a single aortic arch branch vessel The GORE TAG Thoracic Branch Endoprosthesis is a modular device consisting of the Aortic Component (AC), the Side Branch (SB) Component, and an optional Aortic Extender (AE), and their respective delivery systems. These components may be used together as a stand-alone device or in conjunction with the GORE TAG Conformable Thoracic Endoprosthesis to accommodate the intended treatment site.

Due to catheter separation

On 05/21/2026, the firm thru a third-party (Sedgwick) sent via certified mail an "URGENT Medical Device Safety Correction/Field Safety Notice" informing customer that Gore received 5 reports involving catheter separation of the GORE TAG Thoracic Branch Endoprosthesis (TBE) Side Branch (SB) Component during clinical use. In all cases, the failure occurred at the interface between the main catheter shaft and an over molded transition near where the trailing end of the device is positioned on the catheter. Customers are being reminded of pertinent Instructions for Use and Warnings and Considerations. -Per the IFU - Gore recommends use of a through-and-through side branch wire where clinically and anatomically feasible. -rotation of the SB delivery catheter is cautioned against: Caution: Do not rotate the SB Component delivery catheter. Catheter breakage or inadvertent deployment has occurred. -Caution: Do not continue advancement or retraction of the & delivery catheter if resistance is felt. Stop and assess the cause of resistance. Vessel, endoprosthesis, or delivery catheter damage may occur. -Complete and sign the "RETURN ACKOWLEDGEMENT FORM" and return to [email protected] and share notice with those within their institution For Questions - contact me, Gore Customer Service (email: [email protected] or by phone at 800-528-8763), or your local Field Sales Associate.