INDICATIONS, SAFETY, AND WARNINGS Tri-Ad Adams Tricuspid Annuloplasty Ring

Indications: Tri-Ad Adams tricuspid annuloplasty rings are for use in patients undergoing surgery for diseased or damaged tricuspid valves. The Tri-Ad Adams tricuspid annuloplasty ring provides support for and restricts expansion of the 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: thromboembolic events, dehiscence, hemolysis, stenosis, residual incompetence, heart block, endocarditis, right ventricular outflow tract obstruction, anticoagulant-related bleeding or hemorrhage.

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.