Mosaic™
Bioprosthesis
305, 310
Instructions for Use
Caution: Federal law (USA) restricts this device to sale by or on the order of a physician.
Trademarks may be registered and are the property of their respective owners.
Explanation of symbols on package labeling
Refer to the device labeling to see which symbols apply to this product.
Nonpyrogenic
Sterile LC: Device has been sterilized using liquid chemical sterilants according to EN/ISO 14160.
Size
Do not reuse
Do not resterilize
Use-by date
Quantity
For US audiences only
Temperature limitation
Serial number
Catalog number
Manufacturer
Date of manufacture
Authorized representative in the European Community
MR Conditional
Manufactured in
Do not use if indicator turns black
Model
1
Figure 1. Opening the valve container
Figure 2. Removing the retainer from the jar
Figure 3. Verifying the serial number and removing the retainer cap
Figure 4. Inserting the valve handle into the Cinch™ holder
2
Figure 5. Removing the valve from the retainer and rinsing
Figure 6. Ratcheting the Cinch holder (aortic)
Figure 7. Removing the Cinch holder (aortic)
Figure 8. Nondeflected Cinch holder (aortic)
3
1. Visible
Figure 9. Fully deflected Cinch holder (aortic)
Figure 10. Ratcheting the Cinch holder (mitral)
Figure 11. Removing the Cinch holder (mitral)
Figure 12. Nondeflected Cinch holder (mitral)
4
Figure 13. Fully deflected Cinch holder (mitral)
Figure 14. Right fibrous trigone (mitral)
5
Bioprosthesis
1. Device description
The Mosaic™ bioprostheses, Model 305 (aortic) and Model 310 (mitral) consist of porcine aortic valves that have been
preserved in buffered 0.2% glutaraldehyde and fitted and secured to cloth-covered flexible stents. The fixation and preservation
with buffered glutaraldehyde solutions minimize the immunogenic potential on the porcine tissue. The cross-linking process of
the porcine aortic root tissue is accomplished by applying hydrostatic pressure to the root while maintaining a zero-pressure
differential across the valve leaflets.
The tissue is treated with an alpha amino oleic acid antimineralization process, AOA™, which has been shown to mitigate
porcine leaflet calcification in animal studies.
The Mosaic bioprostheses are designed for both the aortic position (Model 305) and the mitral position (Model 310). The
sewing ring diameter on the Mosaic Ultra™ bioprosthesis has been reduced to facilitate implantation in patients with small
aortic roots.
The Mosaic bioprostheses are available in the sewing ring diameters and sizes shown in Table 1, Table 2, and Table 3.
Table 1. Mosaic aortic bioprosthesis, Model 305, available sizes and sewing ring diameters
A
Valve size (stent
O.D.a) (±0.5 mm)
Orifice diameter
B
(stent I.D.)
(±0.5 mm)
C
Suture ring
diameter
(±1 mm)
D
Valve height
(±0.5 mm)
E
Aortic protrusion
(±0.5 mm)
19 17.5 25.0 13.5 11.0
21 18.5 27.0 15.0 12.0
23 20.5 30.0 16.0 13.5
25 22.5 33.0 17.5 15.0
27 24.0 36.0 18.5 15.5
Nominal values in millimeters 29 26.0 39.0 20.0 16.0
a
Stent O.D. equivalent to annulus diameter
Table 2. Mosaic Ultra aortic bioprosthesis small root system, Model 305, available sizes and sewing ring diameters
A
Valve size (stent
O.D.a) (±0.5 mm)
Orifice diameter
B
(stent I.D.)
(±0.5 mm)
C
Suture ring
diameter
(±1 mm)
D
Valve height
(±0.5 mm)
E
Aortic protrusion
(±0.5 mm)
19 17.5 24.0 13.5 11.0
21 18.5 26.0 15.0 12.0
23 20.5 28.0 16.0 13.5
25 22.5 30.0 17.5 15.0
27 24.0 32.0 18.5 15.5
Nominal values in millimeters 29 26.0 34.0 20.0 16.0
a
Stent O.D. equivalent to annulus diameter
Table 3. Mosaic mitral bioprosthesis, Model 310, available sizes and sewing ring diameters
A
Valve size (stent
O.D.a) (±0.5 mm)
Orifice diameter
B
(stent I.D.)
(±0.5 mm)
C
Suture ring
diameter
(±1 mm)
D
Valve height
(±0.5 mm)
E
Mitral protrusion
(±0.5 mm)
25 22.5 33.0 18.0 13.5
27 24.0 35.0 19.0 14.0
29 26.0 38.0 20.5 15.5
31 28.0 41.0 22.0 17.0
Nominal values in millimeters 33 30.0 43.0 23.0 17.5
a
Stent O.D. equivalent to annulus diameter
2. Indications for use
The Mosaic bioprostheses are indicated for the replacement of malfunctioning native or prosthetic aortic and/or mitral heart
valves.
3. Contraindications
No contraindications for use of this device are known.
6 Instructions for Use English
4. Warnings and precautions
4.1. Warnings
This device was designed for single patient use only. Do not reuse, reprocess, or resterilize this product. Reuse, reprocessing,
or resterilization may compromise the structural integrity of the device or create a risk of contamination of the device, which
could result in patient injury, illness, or death.
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 will render the bioprosthesis unfit for use.
Do not use the bioprosthesis if:
■
The bioprosthesis has been dropped, damaged, or mishandled in any way
■
The Use-by date has elapsed
■
All tamper strips on the glass jar and lid container are damaged
■
The serial number tag does not match the container label
■
The shipping temperature indicator window has turned black
■
The glutaraldehyde storage solution does not completely cover the bioprosthesis
Do not expose the bioprosthesis to solutions other than the storage solution in which it was shipped, the sterile isotonic saline
solution used during the rinsing procedure, or the sterile isotonic saline solution used to irrigate the bioprosthesis.
Do not add antibiotics to either the storage or the rinse solution. Do not apply antibiotics to the bioprosthesis.
Do not allow the valve tissue to dry. Maintain tissue moisture with irrigation or immersion in normal saline solution during
surgery.
Do not attempt to repair a damaged bioprosthesis.
Do not use cutting needles, as they may cause structural damage to the fabric of the bioprosthesis.
Do not pass a catheter, surgical instrument, or transvenous pacing lead through the bioprosthesis, as this may damage the
valve.
Do not oversize. Implanting too large a valve in a patient can lead to stent distortion or valve inflow obstruction and an
increased risk for stenosis, regurgitation, or reduced valve durability.
Implanting too small a valve in a patient can lead to an increased risk for stenosis.
4.2. Precautions
■
Accelerated deterioration due to calcific degeneration of bioprostheses may occur in:
■
Children, adolescents, or young adults
■
Patients with altered calcium metabolism (eg, chronic renal failure, hyperparathyroidism)
■
When selecting a bioprosthesis size, consideration of the cardiac anatomy is necessary, and care must also be taken to
select a bioprosthesis which adequately provides for the hemodynamic requirements of the patient.
■
When using interrupted sutures, it is important to cut the sutures close to the knots and to ensure that exposed suture tails
will not come into contact with the leaflet tissue.
■
Care must be exercised when placing sutures through the sewing ring to avoid possible laceration of the leaflet tissue.
■
Do not use other manufacturers' sizers or universal sizers to size the Mosaic bioprosthesis.
5. Adverse events
A prospective, nonrandomized, multi-center clinical study was conducted to assess the safety and effectiveness of the Mosaic
bioprosthesis. Patients were evaluated preoperatively, within 30 days postoperative, 3 to 6 months postoperative, at 1 year
(11 to 14 months) postoperative, and annually thereafter. Patients were monitored throughout the postoperative period for
possible adverse events.
5.1. Original PMA data
One thousand two hundred fifty-two (1252) patients had isolated aortic valve replacement (AVR) and 365 patients had isolated
mitral valve replacement (MVR). Mortality and valve-related morbidity rates after implantation with the Mosaic bioprosthesis are
summarized in the following tables.
Observed adverse events
Isolated aortic valve replacement (AVR)
The adverse event rates were based on 1252 bioprostheses implanted in 1252 patients at 17 centers. The cumulative follow-up
was 2745.3 patient-years with a mean follow-up of 2.2 years (SD=1.2 years, range=0 to 5.2 years).
Instructions for Use English 7
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