Edwards Lifesciences 4400 User manual

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Carpentier-Edwards Classic
• Annuloplasty Ring for Mitral and Tricuspid Valvuloplasty
• Pierścień do annuloplastyki zastawki mitralnej i trójdzielnej
• Anuloplastický krúžok pre mitrálnu a trikuspidálnu valvuloplastiku
Model 4400/4500
For Single Use Only
Rx only
Concept/Description
The Carpentier-Edwards Classic Annuloplasty Ring is constructed of titanium
alloy and has a sewing ring margin that consists of a layer of silicone rubber
covered with a polyester knit fabric. Design objectives include: retention of
the natural valve apparatus, remodeling of the annulus, retention of a
normal valve orifice during systole, and prevention of secondary distension
of the annulus (frequently the cause of recurrent incompetence after
conventional valvuloplasties).
The mitral ring conforms to the configuration of a normal mitral orifice.
It is kidney-shaped with one long curved segment corresponding to the
posterior leaflet.The ring is open in the rectilinear portion corresponding to
the anterior leaflet (Figure 1) and has transverse colored threads indicating
the anterior and posterior commissures (Figure 2).
The oval tricuspid ring conforms to the configuration of a normal tricuspid
orifice.The ring has one rectilinear segment corresponding to the septal
leaflet and one long curved segment corresponding to the anterior and
posterior leaflets.The ring is open at the anteroseptal commissure
(Figure 3). Transverse colored threads indicate the site of the
anteroposterior and posteroseptal commissures (Figure 4).
Safety in the Magnetic Resonance (MR) Environment:
MR Conditional
Non-clinical testing has demonstrated that the Carpentier-Edwards Classic
Annuloplasty Ring (models 4400/4500), is MR Conditional. A patient with
the Carpentier-Edwards Classic Annuloplasty Ring, can be scanned safely,
immediately after placement of this implant under the following conditions:
• Static magnetic field of 3 tesla or less
• Maximum spatial magnetic gradient field of 720 gauss/cm or less
• Maximum MR system reported, whole-body-averaged specific
absorption rate (SAR) of 3W/kg for 15 minutes of scanning
(i.e. per pulse sequence)
In non-clinical testing, Carpentier-Edwards Classic Annuloplasty Ring
(models 4400/4500), produced a temperature rise of less than or equal to
0.6°C at a maximum whole-body-averaged specific absorption rate (SAR)
of 3 W/kg for 15 minutes of MR scanning in a 3 tesla MR system
(Excite, General Electric Healthcare, Software G3.0-052B).
MR image quality may be compromised if the area of interest is in the same
area or relatively close to the position of the device. Optimization of MR
imaging parameters is recommended.
Ring Valvuloplasty Techniques
Established surgical technique can be used in correction of mitral and/or
tricuspid valvular insufficiencies.These techniques allow for remodeling of
the valvular apparatus with a tailored annuloplasty ring of appropriate size
and shape.The ring is placed in the atrial position and sutured to the
natural annulus.
DIRECTORY
English . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .1
Polski . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 6
Slovensky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11
References/Piśmiennictwo/Literatúra . . . . . . . . . . . . . . . . . . . . . . 15
Specifications/ Specyfikacja/Technické špecifikácie . . . . . . 16–17
Figures/Ryciny/Obrázky . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17–18
Symbol Legend/Wykaz symboli/Legenda k symbolom . . . . . . . 19
English
Edwards Lifesciences, the stylized E logo, and Carpentier-Edwards Classic are
trademarks of Edwards Lifesciences Corporation and are registered in the U.S.
Patent and Trademark Office.
Klenzyme is a registered trademark of Merck & Co., Inc.
Instru-Klenz is a trademark of STERIS Corporation.
Cidex and Cidezyme are registered trademarks of Advanced Sterilization Products,
a Johnson & Johnson Company and Division of Ethicon, Inc.

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The techniques reposition displaced and incompetent valvular cusps,
remodel the distended cusps and commissures, and reduce annular
dilatation by staged plication at several points. Clinical results indicate a
reduction in thromboembolic risk, as compared to valvular replacement, and
elimination of the need for long-term postoperative anticoagulation therapy
in most patients.
When compared with other techniques, prosthetic ring valvuloplasty offers
the following advantages:
1. Correction of dilatation as well as deformation of the valvular annulus,
conserving optimal orificial area.
2. Selective reduction of dilated and deformed zones preserving normal
leaflet function.
3. Correction based on precise measurement of the valvular apparatus
providing a predictable result.
4. Prevention of recurrent dilatation or deformation.
Additional features of valvuloplasty rings include:
1. In the tricuspid ring, the opening is at the anteroseptal commissure,
thus avoiding sutures in the area of the bundle of His.
2. Transverse colored thread facilitates location of the commissures and
proper positioning of the ring.
3. Small size and profile of the rings minimize the exposure of
foreign material in the atrium and may account for the reduced
thromboembolic incidence as compared with prosthetic valves.
Indications
The decision to undertake valvuloplasty can be made only after visual analysis
of the lesion present. The most favorable conditions for valvuloplasty using an
annuloplasty ring are a combination of a distended natural valve ring associated
with supple valve cusps and normal chordae tendineae.
Mitral
The remodeling valvuloplasty technique with a prosthetic ring may be
used in all acquired or congenital mitral insufficiencies with dilatation
and deformation of the fibrous mitral annulus.
ForType I mitral insufficiencies with no subvalvular lesions and normal
valvular movements, this ring technique used alone is sufficient. However,
the ring technique must be associated with mitral valvuloplasty repair in
Type ll insufficiencies with a prolapsed valve due to elongation or rupture
of the chordae tendineae and in Type lll insufficiencies with limitation of
valvular movements due to fusion of the commissures or chordae tendineae,
or chordal hypertrophy.
Tricuspid
The primary indication for this technique is acquired tricuspid insufficiency,
whether functional or organic. Indications for tricuspid repair are based on
the evolution of the insufficiency as diagnosed by angiography and dye
dilution curves during preoperative medical treatment. In patients with
an irreversible tricuspid insufficiency, the condition should be corrected.
Completely reversible insufficiencies should not, however, be corrected
by ring annuloplasty.
Partially reversible tricuspid insufficiencies should be explored and the orifice
measured using the appropriate sizers. If the area of the orifice is significantly
larger than the size 32 sizer in women, size 34 in men, or if organic lesions of
the leaflets are present, the insufficiency should be corrected.
Combined tricuspid insufficiency and stenosis should be corrected by a triple
commissurotomy and valvular remodeling. Severe organic lesions of the
posterior leaflet should be treated by two incisions, one at the anteroseptal
commissure, the other at the posterior leaflet.
Contraindications
1. Severe organic lesions with retracted chordae
2. Congenital malformations with lack of valvular tissue
3. Large valvular calcifications
4. Evolving bacterial endocarditis
Warnings
For Single Patient Use Only
This device is designed, intended, and distributed for single use only. Do not
reuse this device. There are no data to support the sterility, nonpyrogenicity
and functionality of the device after reuse and reprocessing.
The decision to use an annuloplasty ring must ultimately be made by the
physician on an individual basis after carefully evaluating the short- and
long-term risks and benefits to the patient as compared to alternative
methods of treatment.
As with any implanted device, there is potential for an
immunological response.
It is recommended that anticoagulants be used for the first two months
postoperatively, except where contraindicated, to promote a gradual healing
of the exposed cloth and sutures.
Recipients of annuloplasty rings who are undergoing dental procedures or
other surgical procedures should receive prophylactic antibiotic therapy to
minimize the possibility of systemic infection.
Do not attempt to deform or otherwise alter the configuration of the
annuloplasty ring to conform to a specific annular anatomy, as this could
damage the ring. If the ring is not suitably sized for the annulus, a larger
or smaller ring should be chosen.
The double-packaged container in which Carpentier-Edwards Classic
Annuloplasty Rings are provided is not suitable for autoclave resterilization
procedures. If resterilization is necessary, the rings should be
removed and transferred to a suitable container.
Precautions
Before clinical application, surgeons should become familiar, by appropriate
training, with the surgical technique and its variations. In addition to
the guidelines provided here, it is important that the references listed
herein be reviewed.
A serial number tag is attached to the prosthesis by a suture.This tag should
not be detached from the prosthesis until implant is imminent. Care should be
exercised to avoid cutting or tearing of the cloth during removal of the tag.

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To avoid damage to the fabric covering the ring, suture needles with
cutting edges and metal forceps must not be used during insertion.
For ease of orientation, the sewing ring is marked with a colored thread
(Figures 2 & 4).This side of the ring must lie against the valve annulus.
Complications
A full explanation of the benefits and risks should be given to each
prospective patient before surgery.
Serious complications, sometimes leading to death, have been associated
with the use of annuloplasty rings. In addition, complications due to
individual patient reaction to an implanted device, or to physical or chemical
changes in the components, may necessitate reoperation and replacement
(sometimes within weeks or months) of the prosthetic device.
Careful and continuous medical follow-up is advised so that prosthesis-related
complications can be diagnosed and properly managed to minimize danger
to the patient.
Complications associated with annuloplasty ring valvuloplasty include:
residual or recurrent valvular insufficiency; stenosis; thromboembolism;
hemolysis; A-V block; low cardiac output; right heart failure; failure
or degeneration of the patient’s natural valvular apparatus due to
progression of disease, endocarditis, local and/or systemic infection or
inadequate/incomplete repair of the valvular and subvalvular structures;
suture obliteration of the circumflex coronary artery; complications related
to prolonged bypass, aortic cross clamping, and inadequate myocardial
protection; partial dislodgment of the ring from its site of attachment;
malfunction of the ring due to distortion at implant or physical or chemical
deterioration of ring components; tearing of the cloth covering with the use
of cutting needles; bleeding diatheses related to the use of anticoagulant
therapy; and systolic anterior motion (S.A.M.) and left ventricular outflow
tract obstruction (L.V.O.T.O.) whenever a large posterior leaflet is present.
Instructions for Use
Mitral
Measurement and Selection of the Appropriate Ring
Because the intention of the technique of valvular remodeling is to restore
a physiological orifice, measurement and ring selection is based on the
measurement of the anterior leaflet attachment by using sizers with two
notches on their linear segment (Figure 5). Since the delineation of the
anterior leaflet may be difficult, the ring may also be selected by measuring
the surface of the anterior leaflet with the same sizers (Figure 6).
To facilitate this measurement, the chordae tendineae may be placed
on tension, thus spreading the leaflet.The most commonly used sizes
are 30 and 32 in women, and 32 and 34 in men.
CAUTION: Examine sizers and handles for signs of wear, such as dullness,
cracking or crazing. Replace sizer/handle if any deterioration is observed.
WARNING: Fragments of the sizers/handles cannot be located by means of
an external imaging device.
Insertion of the Mitral Prosthesis
Insertion of the mitral prosthesis can be done by interrupted horizontal
sutures in the fibrous mitral annulus 2 mm from the leaflet hinge.
Approximately 10 to 12 sutures are needed.
To facilitate exposure of the mitral annulus for passing the suture, the leaflet
should be tensed with forceps.
A precise relationship between leaflet and corresponding segments of the
prosthetic ring should be maintained (Figure 7).
Note: The side of the ring with the colored thread around the
circumference always lies against the annulus.
Figure 8 illustrates the appearance of the properly implanted ring.
Testing
Valvular competency is tested by injecting saline into the left ventricle
through the mitral orifice and then verifying whether the coaptation line is
visible, regular and symmetrical. Intraoperative echo has been instrumental
in assessing valvular competency and the quality of repair.
If use of established surgical techniques in conjunction with ring
annuloplasty fails to produce adequate repair of valvular insufficiency as
determined by visual inspection or intraoperative testing, the surgeon must
be prepared to remove the ring and replace the diseased valve with a
prosthetic valve during the same procedure.
Tricuspid
Measurement and Selection of the Appropriate Ring
Because the intention of the technique of valvular remodeling is to restore a
physiological orifice, measurement and ring selection are important aspects
of the operation.
Ring selection must be based on the measurement of the septal leaflet
attachment by using sizers with two notches on their linear segment (Figure 9).
Since the delineation of the septal leaflet may be difficult, the ring can also
be selected by measuring the surface of the anterior leaflet using the same
sizers (Figure 10). To facilitate this measurement, the chordae tendineae
rising from the anterior papillary muscle may be pulled out with a nerve
hook, thus spreading the leaflet. Usually a size 32 ring is selected in women
and a size 34 in men, except when there are organic lesions.
CAUTION: Examine sizers and handles for signs of wear, such as dullness,
cracking or crazing. Replace sizer/handle if any deterioration is observed.
WARNING: Fragments of the sizers/handles cannot be located by means of
an external imaging device.
Insertion of the Prosthesis
The insertion of the prosthesis can be carried out either by interrupted or
continuous sutures (Figures 11 through 15). Care should be taken to avoid
placing a suture through the area of the bundle of His.
Note: The side of the ring with the colored thread around the
circumference always lies against the annulus.
To facilitate exposure of the tricuspid annulus and to avoid catching the
chordae tendineae by a suture, the following procedure should be followed.
The leaflet should be tensed perpendicular to the atrial wall when passing
the needle through the annulus towards the ventricular cavity and then
towards the atrium (Figure 11).

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Whatever the technique used, the principles remain the same:
1. Precise relationship among leaflets and corresponding segments of
the prosthetic ring should be maintained.
2. Sutures should be placed through the annulus 2 mm from the leaflet
hinge to preserve leaflet function.
3. The first suture should be placed at the midpoint of the septal
leaflet (Figure 11).
Testing
Digital exploration of a tricuspid valve repair has little value because
of abnormal hemodynamic conditions during the operation, i.e., low
pulmonary artery pressure, ventricular compliance.
Intracardiac digital exploration may underestimate a regurgitation, and
may not detect a moderate stenosis. The injection of saline into the right
ventricle is only valuable if a normal pressure can be obtained in the right
ventricle with a beating heart. However, if the measurement of the orifice,
the ring selection, and insertion have been carefully done, a good result
can usually be expected.
If careful application of the ring method of annuloplasty fails to produce
adequate repair of valvular insufficiency as determined by visual inspection or
intraoperative testing, the surgeon must be prepared to remove the ring and
replace the diseased valve with a prosthetic valve during the same procedure.
Annuloplasty Ring
Specifications
Carpentier-Edwards Classic Annuloplasty Ring.
Model 4400 for the mitral position.
Sizes: 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 36 mm, 38 mm, 40 mm.
Carpentier-Edwards Classic Annuloplasty Ring.
Model 4500 for the tricuspid position.
Sizes: 26 mm, 28 mm, 30 mm, 32 mm, 34 mm, 36 mm.
How Supplied
Carpentier-Edwards Classic Annuloplasty Rings are provided sterile and
nonpyrogenic in double plastic trays to facilitate handling and transfer to
the sterile field at the time of surgery. After opening the outer tray, the
inner tray may be placed directly into the sterile field.
If a tray is open or compromised, but the annuloplasty ring is not used,
soiled, dropped or damaged, the ring may be resterilized
(see Resterilization).
Storage
To minimize contamination and to provide maximum protection,
the prosthesis should be stored in the outer cardboard box in a dry,
contamination free area until needed. Stock rotation at regular intervals
is recommended to ensure usage of the ring before the expiration date
stamped on the label.The annuloplasty ring cannot be used after the date
stamped on the package.
Accessories
Sizers corresponding to the various sizes of mitral and tricuspid rings are
available (see Specifications). These sizers should be used at the time of
operation for accurate selection of the appropriate size ring for each patient.
The sizers and sizer handles are provided nonsterile and must be sterilized
before using (see Resterilization).
Sizers and handles must be disassembled, cleaned and resterilized before
each subsequent use.The sizers and sizer handles must be removed from
their packages before sterilization (see Resterilization).
The sizers and sizer handles are intended for multiple use as long as they are
properly handled and inspected before using.
Cleaning Instructions
Instructions for Automated Cleaning:
Pre-rinse (as needed): Klenzyme enzymatic anionic detergent or equivalent.
Cleaning: Clean instruments within tray and with lid detached prior to
initial use and after each use with a nonionic detergent cleaning solution
(example Instru-Klenz) in a mechanical washer (example STERIS AMSCO
Reliance 444), minimum 2 minute wash phase.
Instructions for Manual Cleaning:
Pre-rinse (as needed): Per hospital procedure.
Cleaning: Place the sizer, handle, tray base, and tray lid instruments in a
cleaning solution bath, such as Cidezyme, an enzymatic detergent, for the
time and temperature specified by its manufacturer. Ensure that the
instruments are covered and do not touch each other. Clean the accessories
thoroughly with a soft plastic brush for 5 minutes; remove any superficial
impurities with the soft brush. Never use metal brushes or steel wool on
the instruments. Always use fresh cleaning solution between cleanings.
Afterwards, rinse each accessory thoroughly 5 times for 1 minute with
sterile, deionized water.
Disinfection: Place the cleaned and inspected instruments in disinfection
solution (example Cidex OPA) for the time and temperature specified by the
manufacturer. Ensure that the instruments are covered and do not touch
each other. Afterwards, rinse each instrument thoroughly 5 times for
1 minute with sterile, deionized water.
The user is responsible for the qualification of any deviations from the
recommended method of cleaning.
CAUTION: Examine sizers and handles for signs of wear, such as dullness,
cracking or crazing. Replace sizer/handle if any deterioration is observed.
Resterilization by Steam
When resterilization is contemplated, each institution should establish
sterilization procedures that include biological indicators to establish the
efficacy of their procedure.
It is recommended that the rings be resterilized no more than five times.
Annuloplasty rings cannot be used after the date stamped on the package.
Rings, sizers, and handles must first be removed from their packages. It is
recommended, however, that a suitable outer wrap be used if storage
is contemplated.

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The following conditions are recommended:
For the Annuloplasty ring and Accessories:
Gravity Displacement:
Wrapped:
Temperature: 132°C–135°C (270°F–275°F)
Exposure Time: 10–15 minutes
Unwrapped (“flash”):
Temperature: 132°C (270°F)
Exposure Time: 3 minutes
Prevacuum:
Wrapped:
Temperature: 132°C–135°C (270°F–275°F)
Exposure Time: 3–4 minutes
Unwrapped (“flash”):
Temperature: 132°C (270°F)
Exposure Time: 3 minutes
The user is responsible for the qualification of any deviations from the
recommended method of sterilization.
WARNING: Do not stack trays during sterilization.
Gamma radiation should never be used for sterilization of
Carpentier-Edwards Classic Annuloplasty Rings, as this may
result in deterioration of the sewing ring.
Case History
Implant Patient Registry
When each Edwards annuloplasty ring is used, carefully complete the
Implantation Data Card that is packaged with each device. Return the
preaddressed portion of the card to our Implant Patient Registry.The
remaining portions of the card are provided for hospital and surgeon
records. Upon receipt by our Registry, a wallet-sized identification card will
be produced for the patient. This card allows patients to inform healthcare
providers what type of implant they have when they seek care. When a ring
is discarded the implantation data card should be used to report this
information to our Registry.
Recovered Clinical Implants
Edwards Lifesciences Corporation is extremely interested in obtaining
recovered clinical specimens of Carpentier-Edwards Classic Annuloplasty Rings
for analysis. A written report summarizing our findings will be provided upon
completion of our evaluation. Please contact your local company
representative for return of recovered rings. The rings should be placed in a
suitable histological fixative, such as 10% formalin or 2% glutaraldehyde.
Refrigeration is not necessary under these circumstances.
Kits to return the explanted rings are available upon request.
Prices and model availability are subject to change without notice.