Medtronic 995CS19 Instructions for Use
Freestyle™
995CS, 995MS Bioprosthesis
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.
Use-by date
Serial number
Do not reuse
Sterile LC: Device has been sterilized using liquid chemical sterilants according to EN/ISO 14160.
Temperature limitation
Size
For US audiences only
Catalog number
MR Safe
Authorized representative in the European Community
Manufacturer
Do not resterilize
Quantity
Nonpyrogenic
Do not use if indicator turns black
Manufactured in
Model
Date of manufacture
1
Figure 1. Opening the valve container
Figure 2. Removing the retainer from the jar
Figure 3. Removing the cap from the valve retainer body
Figure 4. Removing the bioprosthesis from the retainer
2
Figure 5. Releasing the identification tag (serial number)
Figure 6. Rinsing the bioprosthesis
Figure 7. Screwing the valve holder onto the handle
Figure 8. Removing the valve holder, method 1
Figure 9. Removing the valve holder, method 1
3
Figure 10. Removing the valve holder, method 2
Figure 11. Removing the valve holder, method 2
4
Bioprosthesis
3 mm ± 0.5
A
Valve height
minimum 9 mm
above highest
commissure
3 mm ± 0.5
A
Valve height
minimum 9 mm
above highest
commissure
1. Device description
The Freestyle™ modified subcoronary bioprosthesis, Model 995MS, and the Freestyle™ complete subcoronary bioprosthesis,
Model 995CS, consist of a porcine aortic root scalloped for aortic valve replacement. The modified subcoronary bioprosthesis is
scalloped at the right and left coronary sinuses. The complete subcoronary bioprosthesis is scalloped at each of the 3 sinuses.
The Freestyle subcoronary bioprostheses are preserved in buffered 0.2% glutaraldehyde with a cloth covering added to
strengthen the proximal (inflow) suture line and to cover any exposed porcine myocardium. The fixation and preservation with
buffered glutaraldehyde solutions minimize the immunogenic potential on the porcine tissue.
The Freestyle subcoronary bioprostheses are treated with an alpha amino oleic acid antimineralization process, AOA™, which
has been shown to mitigate porcine leaflet calcification in animal studies.
The Freestyle subcoronary bioprostheses are available in the diameters and sizes shown in Table 1 and Table 2. Each
bioprosthesis is supplied with a valve holder to aid in valve handling before and during the implantation procedure.
Table 1. Freestyle complete subcoronary bioprosthesis, Model 995CS available sizes and dimensions
Size (mm) A
Outside diameter (+0.5 mm-0.0 mm)
19 19.0
21 21.0
23 23.0
25 25.0
27 27.0
Table 2. Freestyle modified subcoronary bioprosthesis, Model 995MS available sizes and dimensions
Size (mm) A
Outside diameter (+0.5 mm-0.0 mm)
19 19.0
21 21.0
23 23.0
25 25.0
27 27.0
29 29.0
2. Indications for use
The Freestyle subcoronary bioprostheses are indicated for the replacement of malfunctioning native or prosthetic aortic valves.
3. Contraindications
No contraindications for use of this device are known.
Instructions for Use English 5
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 and/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 in any of the following circumstances:
■
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 number on 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 tissue of the bioprosthesis 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.
4.2. Precautions
■
Accelerated deterioration due to calcific degeneration of bioprostheses may occur in the following individuals:
■
Children, adolescents, or young adults
■
Patients with altered calcium metabolism (eg, chronic renal failure, hyperparathyroidism)
■
When selecting a bioprosthesis size, the cardiac anatomy must be considered, and care must be taken to select a
bioprosthesis that adequately provides for the patient's hemodynamic requirements.
■
Implanting physicians must be familiar with the techniques for implanting an unstented bioprosthesis. These techniques are
similar to those required for allograft implantation.
■
In vitro testing of the Freestyle subcoronary bioprosthesis has only been performed in less compliant, simulated aortae
comparable to those of middle aged or older patients. Data from clinical or in vitro testing are not available from more
compliant, simulated aortae comparable to those of younger patients.
■
Do not invert the valve. Inversion will damage valve tissue.
Note: The leaflets of the Freestyle bioprosthesis are in an open position. Use extreme caution to avoid cutting or puncturing
the leaflets when tailoring and suturing the bioprosthesis.
■
Use of pledgets anywhere within the interior aspect of the bioprosthesis is not recommended.
■
Trim suture ends close to the knot to prevent abrasion of leaflet tissue.
5. Adverse events
5.1. Original premarket application (PMA) data (complete subcoronary configuration: sizes 19-27 mm)
A prospective, nonrandomized, multicenter, international study evaluated the Freestyle bioprosthesis with patient follow-up out
to 3 years. A total of 882 patients received the bioprosthesis. Patients were monitored throughout the entire postoperative
period for possible adverse events. The cumulative follow-up was 1246 patient-years with a mean follow-up of 17 months
(standard deviation [SD] = 12 months, range = 0 to 42 months).
Observed adverse events
Subcoronary technique (sizes 19-27 mm)
Note: All clinical results reflect data from the original PMA submission for the Freestyle bioprosthesis, Model 995,
which was custom trimmed by the implanting physician.
6 Instructions for Use English
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