Idiomas disponibles
Idiomas disponibles
11. Verify the correct position of the valve with respect to the landing
zone.
12. As necessary, utilize the Flex Wheel to adjust the coaxial orientation
of the valve and the Fine Adjustment Wheel to adjust the position
of the valve.
13. Before deployment, ensure that the valve is correctly positioned
between the Valve Alignment Markers and the Flex Catheter tip is
locked over the Triple Marker.
14. Begin valve deployment:
• Unlock the inflation device provided by Edwards Lifesciences.
• Using slow controlled inflation, deploy the valve by inflating the
balloon with the entire volume in the inflation device provided by
Edwards Lifesciences, hold for 3 seconds and confirm that the
barrel of the inflation device is empty to ensure complete
inflation of the balloon.
• Deflate the balloon.
8.3.2.2 Procedure with GORE DrySeal Flex Introducer Sheath
1.
Gain access using standard catheterization techniques.
2.
Prepare the GORE DrySeal Flex Introducer Sheath. Refer to the GORE
DrySeal Flex Introducer Sheath IFU for information on device
preparation and handling.
3.
If necessary, predilate the vessel.
4.
Introduce the sheath per its instructions for use.
5.
Insert the delivery system into the sheath.
6.
Advance the delivery system, with the Edwards logo in the proper
orientation (the delivery system articulates in a direction opposite
from the flush port), through the sheath.
Note: The delivery system articulates in a direction opposite
from the flush port.
CAUTION: The valve should not be advanced through the sheath
if the sheath tip is not past the IVC bifurcation to minimize the
risk of damage to the iliac vessel(s).
CAUTION: To prevent possible leaflet damage, the valve should
not remain in the sheath for over 5 minutes.
7.
Advance the catheter to the landing zone.
8.
Expose the valve by retracting the GORE DrySeal Flex Introducer
Sheath tip beyond the Triple Marker.
9.
Disengage the Balloon Lock and retract the tip of the Flex Catheter
to the center of the Triple Marker. Engage the Balloon Lock.
10. Verify the correct position of the valve with respect to the landing
zone.
11. As necessary, utilize the Flex Wheel to adjust the coaxial orientation
of the valve and the Fine Adjustment Wheel to adjust the position
of the valve.
12. Before deployment, ensure that the valve is correctly positioned
between the Valve Alignment Markers and the Flex Catheter tip is
locked over the Triple Marker.
13. Begin valve deployment:
• Unlock the inflation device provided by Edwards Lifesciences.
• Using slow controlled inflation, deploy the valve by inflating the
balloon with the entire volume in the inflation device provided by
Edwards Lifesciences, hold for 3 seconds and confirm that the
barrel of the inflation device is empty to ensure complete
inflation of the balloon.
• Deflate the balloon.
8.3.3 System Removal
1.
Unflex the delivery system. Verify that the Flex Catheter tip is locked
over the Triple Marker.
If using the Edwards provided sheath, remove the delivery system
from the sheath.
If using the GORE DrySeal Flex Introducer Sheath, retract the sheath
and delivery system into the vena cava, then remove the delivery
system from the sheath.
CAUTION: Patient injury could occur if the delivery system is not
unflexed prior to removal.
2.
Remove all devices when the ACT level is appropriate.
Refer to the Edwards sheath or the GORE DrySeal Flex Introducer
Sheath instructions for use for device removal.
3.
Close the access site.
9.0 How Supplied
STERILE: The valve is supplied sterilized with glutaraldehyde solution.
The delivery system and accessories are supplied sterilized with ethylene
oxide gas.
The THV is supplied nonpyrogenic packaged in buffered glutaraldehyde,
in a plastic jar to which a tamper evident seal has been applied. Each jar
is shipped in a shelf box containing a temperature indicator to detect
exposure of the THV to extreme temperature. The shelf box is enclosed in
Styrofoam prior to shipping.
9.1 Storage
The valve must be stored at 10 °C to 25 °C (50 °F to 77 °F). Each jar is
shipped in an enclosure containing a temperature indicator to detect
exposure of the valve to extreme temperature.
The delivery system and accessories should be stored in a cool, dry place.
10.0 MR Safety
MR Conditional
Non-clinical testing has demonstrated that the Edwards SAPIEN 3
transcatheter heart valve is MR Conditional. A patient with this device
can be scanned safely, immediately after placement of this device under
the following conditions:
• Static magnetic field of 1.5 tesla (T) or 3.0 tesla (T)
• Maximum spatial gradient field of 2500 Gauss/cm (25 T/m) or less
• Maximum MR system reported, whole body averaged specific
absorption rate (SAR) of 2 W/kg (Normal Operating Mode)
Under the scan conditions defined above, the transcatheter heart valve is
expected to produce a maximum temperature rise of 3.0 °C after
15 minutes of continuous scanning.
In non-clinical testing, the image artifact caused by the device extends as
far as 14.5 mm from the implant for spin echo images and 30 mm for
gradient echo images when scanned in a 3.0 T MRI system. The artifact
obscures the device lumen in gradient echo images.
The implant has not been evaluated in MR systems other than 1.5 T or
3.0 T.
For valve-in-valve implantation or in the presence of other implants,
please refer to the MRI safety information for the surgical valve or other
devices prior to MR imaging.
11.0 Qualitative and Quantitative Information related
to the THV
This device contains the following substance(s) defined as CMR 1B in a
concentration above 0.1% weight by weight:
Cobalt; CAS No. 7440-48-4; EC No. 231-158-0
Current scientific evidence supports that medical devices manufactured
from cobalt alloys or stainless steel alloys containing cobalt do not cause
an increased risk of cancer or adverse reproductive effects.
For THV, the following table shows the qualitative and quantitative
information on the materials and substances:
Substance
Cobalt
Nickel
Chromium
Polyethylene terephthalate
Collagens, bovine, polymers
with glutaraldehyde
Molybdenum
Polytetrafluoroethylene
6
Table 6
CAS
Model Mass Range
(mg)
7440-48-4
131 - 427
7440-02-0
148 - 405
7440-47-3
85.2 - 230
25038-59-9
102 - 170
2370819-60-4
58.3 - 141
7439-98-7
40.3 - 115
9002-84-0
17.5 - 25.5
