Indications For Use; Contraindications; Warnings And Precautions - Medtronic Hancock II Gebrauchsanweisung

Table 3. Hancock II mitral bioprosthesis, Model T510, available sizes and sewing ring diameters
A
Valve size Orifice diameter
a
(stent O.D. )
(±0.5 mm)
25
27
29
31
33
Nominal values in millimeters
a Stent O.D. equivalent to annulus diameter

2. Indications for use

The Hancock II bioprostheses are indicated for the replacement of pathologic or prosthetic aortic and mitral valves.

3. Contraindications

Patients with chronic renal failure, patients undergoing hemodialysis, or patients with abnormal calcium metabolism
may have an increased tendency toward calcification of valvular bioprostheses. Bioprosthetic valves also are
24 Instructions for Use English
B C D
Suture ring Valve height
(stent I.D.) diameter (±0.5 mm)
(±0.5 mm) (±1 mm)
22.5 33.0 18.0
24.0 35.0 19.0
26.0 38.0 20.5
28.0 41.0 22.0
30.0 43.0 23.0
susceptible to calcification in children. Use of the mitral valve in patients with a small, hypertrophied left ventricle
may also be contraindicated because of the potential for outflow tract obstruction or perforation of the ventricular
E
wall by the stent posts. The physician should carefully consider these potential hazards when selecting an
Aortic protrusion appropriate valve substitute for such patients.
(±0.5 mm)

4. Warnings and precautions

4.1. Warnings
13.5
14.0
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse,
15.5
reprocessing, or resterilization may compromise the structural integrity of the device or create a risk of
17.0
contamination of the device, which could result in patient injury, illness, or death.
17.5
Check the shipping temperature indicator inside the carton. If the shipping temperature indicator window is black,
the valve is not suitable for clinical use.
Do not resterilize the valve by any method. Exposure of the bioprosthesis and container to irradiation, steam,
ethylene oxide, or other chemical sterilants renders the bioprosthesis unfit for use.
Do not use any valve that has been damaged. Take extreme care to prevent damage to the delicate valve tissue.
Do not handle the tissue portion of the bioprosthesis with instruments. Even a minor perforation could enlarge in
time to significantly impair valve function. If a valve is damaged during insertion, do not attempt to repair it.
Do not rinse the bioprosthesis in antibiotic solution.