Medtronic Tri-Ad 900SFC Instrucciones De Uso página 14

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
Tri-Ad™
Adams Tricuspid Ring
1. Device Description
The Tri-Ad™ Adams tricuspid ring model 900SFC (Figure 1) consists of
a polished and formed MP35N wire stiffener fitted with two MP35N end
caps and covered with braided polyester fabric. The stiffener runs from
the septal/posterior commissure to the anterior segment distal to the
anterior/posterior commissure to help remodel and stabilize the enlarged
portion of the tricuspid annulus. The Tri-Ad™ Adams tricuspid ring has
three radial green markers. The first is to indicate the end of the stiffener
section at the septal/posterior commissure. The second approximately
marks the posterior/anterior commissure. The third is to indicate the end
of the stiffener section in the anterior segment of the ring. A green
demarcation suture runs around the mid portion of the ring in the stiffener
region. The ring size (26 to 36 mm in 2-mm increments) refers to the
dimension of the ring where the implantation sutures are placed (except
in the stiffener region). The internal stiffener, together with the radiopaque
core in both fully flexible ends of the ring, provides radiographic
visualization along the entire circumference of the ring.
2. Indications
The Tri-Ad™ Adams tricuspid ring is indicated for use in patients
undergoing surgery for diseased or damaged tricuspid valves. The Tri-
Ad™ Adams tricuspid ring provides support for and restricts expansion
of the tricuspid annulus.
3. 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
4. Warnings
■
Only surgeons who have received adequate training to determine
whether incompetent, stenotic, or diseased heart valves are capable
of being repaired or replaced should use this device.
■
Only surgeons who have received appropriate training in valve repair,
including ring implant and sizing techniques, should use this device.
12 Instructions for Use
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