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7. How supplied
7.1. Packaging
The TPV is chemically sterilized and provided sterile and nonpyrogenic in a sealed glass container with a screw cap. Sterility
is compromised if each tamper-evident seal is broken, the container is damaged, or leakage is evident. The outside of the
container is nonsterile and should not be placed in the sterile field.
The delivery system is nonpyrogenic and is sterilized with ethylene oxide gas and packaged in a double pouch. The delivery
system is sterile if the pouches are undamaged and unopened. Do not use the delivery system if the outer pouch is damaged.
The delivery system should never be stored in only the inner pouch. The inner pouch does not provide a sterile barrier. The
outer surfaces of the outer pouch are nonsterile and must not be placed in the sterile field.
7.2. Storage
Store the TPV at 15°C to 25°C (59°F to 77°F). Store the delivery system at room temperature and away from direct sunlight.
The delivery system should never be stored in only the inner pouch. The inner pouch does not provide a sterile barrier.
Appropriate inventory control should be maintained so that devices with the earliest Use By dates are preferentially used to
avoid expiration. Devices must be used by the Use By date shown on the product labels.
8. Instructions for use
The following is a sequential outline of the catheterization/implant procedure. The type of diagnostic catheters, guidewires,
dilation balloons, sizing balloons, or other tools needed are at the discretion of the operator.
8.1. Access site preparation and preimplant diagnostics
1. Perform sterile preparation and draping of the access site.
2. Gain arterial and venous access.
Note: If femoral venous access is not available (for example, due to stenosis or trauma), an alternative venous access site,
such as the internal jugular vein or subclavian vein, can be used for access.
3. Administer heparin to achieve a target ACT of >250 seconds.
4. Introduce a catheter into the arterial sheath and advance it into the ascending aorta. Perform an aortogram to demonstrate
the coronary arteries are not adjacent to the RVOT, and that there is no risk of coronary compression when a stent or a
TPV is implanted.
If the coronaries appear to be in close proximity to the implant site, and coronary compression appears to be
possible, further investigations should be done before moving forward with TPV implantation.
5. Advance an angiographic catheter to the right ventricle (RV) or proximal part of the RVOT for angiography. The
angiographic projections obtained will be based on the relative position of the RVOT.
If assessing a bioprosthesis, adjust the fluoroscopy angles so the bioprosthesis annulus and/or commissures are in one
plane or in profile. Consider the features of the bioprosthesis when determining the optimal placement for the TPV.
6. To assess for suitability of TPV implantation, follow either step a (for conduits) or step b (for bioprosthetic valves).
a. For conduits: Obtain angiographic measurements of the intended implantation site to assess suitability of the conduit
for TPV implantation. If the angiographic measurements are unclear or if there is a question of the conduit being compliant,
a low-pressure sizing balloon (<811 kPa [<8 atm]) may be used to further assess the current condition of the conduit. If the
narrowest conduit dimension (usually in the lateral projection) is ≤18 mm and less than the original conduit diameter,
predilate the site of conduit obstruction (the implantation site) to facilitate optimal relief of conduit obstruction. The size of
the predilation balloon should be at least 2 mm greater than the narrowest diameter of the conduit in any projection, no
more than 110% of the nominal conduit diameter. Perform another conduit angiogram to ensure the conduit is intact. If
there is no conduit injury, repeat the predilation steps, using the same guidelines with increasingly larger balloons until
appropriate implant diameter has been reached.
b. For bioprosthetic valves: Obtain angiographic measurements of the intended implantation site to assess suitability for
TPV implantation. If angiographic measurements are unclear or if there is a question of the inner diameter (ID) of the
bioprosthesis being too large for implant (>22 mm), a low-pressure sizing balloon (<811 kPa [<8 atm]) may be used to
further assess the ID. If the current ID of the bioprosthesis is <22 mm and is ≥2 mm less than the manufacturer's published
ID, use a balloon to predilate the bioprosthesis. The balloon should not exceed the manufacturer's published ID of the
bioprosthesis. If the bioprosthesis ID measures >22 mm, the bioprosthesis should be considered too large for Melody™
TPV implantation.
Note: If obstruction is noted, further preparation of the implantation site (for example, predilation or pre-stenting) may be
required to facilitate optimal relief of obstruction before implanting the TPV.
Instructions for Use
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