Medtronic Tri-Ad 900SFC Instrucciones De Uso página 15

2012/SEP/20 at 4:07 p.m. Doc number: M951612A001 Rev. 1A [16(02)]
Printspec l - 3.75 x 6.0 inches
■
Correct annuloplasty ring sizing is an important element of a
successful valve repair. Undersizing the ring can result in valve
stenosis, ring dehiscence, and/or ring fracture. Oversizing the ring
can result in valve regurgitation and/or ring fracture.
■
Do not place sutures in the coronary sinus, right coronary artery, AV
node or other conduction tissue, as this may result in impairment of
the cardiac conduction system.
■ Suture knots must be securely tied. Loose knots and long suture tails
may be a source for hemolysis, thrombosis, or thromboembolism.
■ Do not cut the ring, as resultant loose threads can be a source of
hemolysis, thrombosis, and/or thromboembolism. In addition,
resultant jagged edges of the stiffener may lead to tissue trauma.
■
Do not alter or deform the ring to conform to annular anatomy as this
could lead to ring fracture, possible valve regurgitation, and stenosis.
■
Do not squeeze the ring with sharp instruments as this may damage
the surface of the stiffener, which may result in ring fracture and
possible tricuspid regurgitation.
■ Intraoperative and/or postoperative echocardiography should be
used to evaluate the effectiveness of the valve repair. Minimizing
regurgitation is an important element of an effective repair.
■
Surgeons who use annuloplasty rings should be current on all
anticoagulation regimens.
■
When postoperative anticoagulant therapy is used, the patient's
anticoagulation status should be carefully monitored.
■
Patients with intra-atrial thrombi or a giant left atrium may benefit from
long-term anticoagulation therapy.
■
The surgeon may desire that patients in atrial fibrillation remain on
anticoagulation therapy until sinus rhythm is established.
■
The ring is indicated for use in the tricuspid position only. Use in the
mitral position may result in ring fracture, mitral regurgitation, and/or
ring dehiscence.
■ When placing the implantation sutures, be careful to avoid snaring
the spokes of the holder.
5. Precautions
■
Do not use cutting edge needles, as they may damage the
annuloplasty device potentially leading to ring dehiscence, ring
fracture, and possible tricuspid regurgitation.
■ Take care not to damage the annuloplasty ring during handling.
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Instructions for Use English 13