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 medtronic.com/manuals.
Note: Manuals can be viewed using a current version of any major internet browser.