6
Warning: The valve must be carefully inspected before
implantation for evidence of extreme temperature exposure
or other damage.
If the indicator shows that the valve has been exposed to extreme
temperatures during transit, do not use the valve. Contact the local
supplier or representative of Edwards Lifesciences to make
arrangements for return, authorization, and replacement. Any
valve returned to the company should be shipped in the same
styrofoam enclosure in which it was received.
Due to the biological nature of this bioprosthesis, and its
sensitivity to physical handling and environmental conditions, it
cannot be returned, except as noted above.
Note:
Products found to have been subjected to freezing or
excessive heat later than 3 days following receipt will be
considered to have resulted from environmental conditions
within the control of the customer, and subject to replacement
at customer’s expense.
10.3 Storage
Carpentier-Edwards bioprostheses should be stored at 10°C to
25°C (50-77°F). Stock inspection and rotation at regular
intervals are recommended to ensure that the valves are used
before the expiration date stamped on the package label.
Caution: Do not freeze. Always store valves in a dry,
contaminationfree area. Any valve that has been frozen, or is
suspected of having been frozen, should not be used for
human implantation.
11. Directions for Use
11.1 Physician Training
No special training is required to implant the Magna
bioprosthesis. The techniques for implanting this bioprosthesis
are similar to those used for supra-annular or intra-annular
placement of any stented aortic bioprostheses.
11.2 Handling and Preparation Instructions
The valve is packaged sterile in a plastic jar with a screw-cap
closure and seal. Before opening, carefully examine the jar for
evidence of damage (e.g. a cracked jar or lid), leakage, or
broken or missing seals.
Caution: Valves from containers found to be damaged,
leaking, without adequate glutaraldehyde, or missing intact
seals must not be used for human implantation.
Caution: It is strongly recommended that a Carpentier-Edwards
PERIMOUNT Magna pericardial bioprosthesis valve not be
opened unless implantation is certain. This is necessary to
reduce the risk of contamination, because it has been
established that glutaraldehyde alone is not a 100% effective
sterilant against all possible contaminants. No attempt should
be made to resterilize a Carpentier-Edwards PERIMOUNT
Magna pericardial bioprosthesis.
Caution: The valve and glutaraldehyde storage solution are
sterile. The outside of the jar is not sterile and must not be
placed in the sterile field.
Remove the seal and screw-lid from the jar. The jar should
contain enough buffered glutaraldehyde storage solution to
cover the prosthesis. The contents of the jar should be handled
in an aseptic manner to prevent contamination.
Using gloved hand, attach the handle to the valve holder while
the valve is still in the container. To do this, simply insert the
handle into the valve holder and turn it clockwise until resistance
is felt. Using handle remove clip and valve from jar. Using gloved
hand grasp clip and continue to rotate the handle until fully
engaged as shown in Figure 1.
Do not grasp the valve.
Be
careful not to exert too much pressure while turning so as to
push the valve off the retainer ring and damage the valve.
Once the handle has been attached, it should not be removed
from the holder until after implantation has been completed
and the handle/holder assembly has been detached as a unit
and removed from the operating field.
Note: The Model 1111 or Model 1126 (single use) handle is
recommended for use with the aortic bioprosthesis.
Remove the clip by grasping the clip edge and slide off parallel
to valve (Figure 2). Discard the clip.
To rinse the valve, place the bioprosthesis in a minimum of 500 ml
of sterile, physiological saline solution. Be sure the saline solution
completely covers the bioprosthesis and holder. With the valve and
holder submerged, slowly agitate the basin (or use the attached
handle to
gently
swirl the valve back and forth for a minimum of
1 minute). Discard the rinse solution. Repeat this process once
using new saline solution for a minimum of 1 minute. The valve
should be left in the final rinse solution until needed to prevent the
tissue from drying.
Caution: Do not allow the tissue to come in contact with the
bottom or sides of the rinse basin during agitation or swirling
of the valve. Care must be taken to ensure that the l.D. tag
does not come in contact with the tissue and injure it. No
other objects should be placed in the rinse basin.
Inspection of the valve and removal of the identification tag are
performed at the time the surgeon calls for the valve.
11.3 Device Implantation
Because of the complexity and variation in the surgical
procedure of cardiac valve replacement, the choice of surgical
technique, appropriately modified in accordance with the
previously described
Warnings, Precautions,
and
Techniques
,
is left to the discretion of the individual surgeon. In general, the
following steps should be used:
1. Surgically remove the diseased or damaged valve leaflets and
all associated structures deemed necessary by the surgeon.
2. Surgically remove any calcium from the annulus to ensure
proper seating of the sewing ring.
3. Measure the size of the annulus using only Carpentier-
Edwards sizers, Model 1130 aortic (Figures 4a-4c). The Model
1130 sizers can be used to measure for either supra-annular
or intra-annular placement, depending on surgeon preference.
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