INDICATIONS, SAFETY, AND WARNINGS Tri-Ad™ 2.0 Adams Tricuspid Annuloplasty Band

Indications: The Tri-Ad 2.0 Adams tricuspid band is indicated for the reconstruction or remodeling of pathological tricuspid valves. The band provides support for and restricts expansion of the tricuspid annulus.

Contraindications: Severe, generalized or localized bacterial endocarditis; heavily calcified valves; greatly dilated annulus (not reducible by standard techniques); severe valvular dysfunction (not correctable by standard techniques); valvular retraction with severely reduced mobility; congenital malformations with lack of valvular tissue.

Warnings/Precautions/Adverse Events: Only physicians who have received proper training in valve repair should use this device. Adverse events can include: uncorrected or recurrent regurgitation, stenosis, band dehiscence, hemolysis (even with mild regurgitation), low cardiac output, heart block, damage to coronary arteries, endocarditis, thrombosis, thromboembolism, anticoagulant-related hemorrhage, band fracture, leaflet perforation, and bleeding diathesis.

Caution: Federal law (USA) restricts these devices to sale by or on the order of a physician.

For a listing of indications, contraindications, precautions, warnings, and potential adverse events, please refer to the Instructions for Use. For countries that use eIFUs, consult instructions for use at this website www.medtronic.com/manuals. Note: Manuals can be viewed using a current version of any major internet browser.