On-X Ascending Aortic Prosthesis User manual

Instructions for Use
On-X®Ascending Aortic Prosthesis
with the Vascutek Gelweave Valsalva™ Graft
1. English.............................................................................................2
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Figures and Tables..............................................................................442

Instructions for Use
On-X®Ascending Aortic Prosthesis
with the Vascutek Gelweave ValsalvaTM Graft
2797
Ascending Aortic Prosthesis
On-X®Ascending Aortic Prosthesis REF ONXAAP

On-X®Ascending Aortic Prosthesis IFU 2
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TABLE OF CONTENTS
1. DEVICE DESCRIPTION..................................................................... 4
2. INDICATIONS................................................................................... 4
3. CONTRAINDICATIONS .................................................................... 4
4. WARNINGS AND PRECAUTIONS.................................................... 5
4.1 Warnings...........................................................................................5
4.2 Precautions .......................................................................................6
5. POTENTIAL ADVERSE EVENTS ....................................................... 7
6. INDIVIDUALIZATION OF TREATMENT ............................................ 7
6.1 Specific Patient Population...............................................................8
7. PATIENT COUNSELING.................................................................... 8
8. HOW SUPPLIED............................................................................... 8
8.1 Available Models and Sizes..............................................................8
8.2 Ascending Aortic Prosthesis Holder Handle ....................................8
8.3 Packaging .........................................................................................8
8.4 Storage .............................................................................................9
8.5 Accessories .......................................................................................9
9. DIRECTIONS FOR USE ................................................................. 10
9.1 Physician Training ...........................................................................10
9.2 Sterilization and Re-sterilization......................................................10
9.3 Handling and Preparation Instructions ...........................................10
9.4 Device Implantation........................................................................12
9.5 Valve Suturing Techniques..............................................................13
9.6 Graft Length and Suturing..............................................................13
9.7 Leaflet Motion Assessment and Valve Rotation .............................14
9.8 Valve Orientation ............................................................................14
10. POSTOPERATIVE INFORMATION ................................................ 15
10.1 Magnetic Resonance Imaging (MRI) Compatibility ......................15
10.2 Returned Goods ...........................................................................16
11. PATIENT INFORMATION.............................................................. 16
11.1 Patient Registration ......................................................................16
11.2 Patient Record Card......................................................................16
12. DISCLAIMER OF WARRANTIES ................................................... 16

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FIGURES AND TABLES..................................................................... 442
Figure 1. On-X®Ascending Aortic Prosthesis ....................................442
Figure 2. On-X®Ascending Aortic Prosthesis with
Holder Handle Assembly.....................................................442
Figure 3. Replica Sizer ........................................................................443
Figure 4. Instrument Handle...............................................................443
Figure 5. Valve Rotator .......................................................................443
Figure 6. Leaflet Probe .......................................................................443
Figure 7. Removing Prosthesis from Inner Package...........................443
Figure 8. Removing Holder Handle from Prosthesis ..........................444
Table 1. On-X Ascending Aortic Prosthesis Specifications (mm)........445
Table 2. Definitions .............................................................................446

On-X®Ascending Aortic Prosthesis IFU 4
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Please note: All Figures and Tables are displayed in the last pages of
this booklet. Please refer to the final pages for illustrations and data.
1. DEVICE DESCRIPTION
Manufactured by On-X Life Technologies, Inc.TM (On-X LTI), the On-X®
Ascending Aortic Prosthesis combines the On-X®Prosthetic Heart Valve
and the Gelweave ValsalvaTM Vascular Prosthesis (Figure 1). The prosthesis
is available in sizes 19, 21, 23, 25, and 27/29 mm. The Gelweave Valsalva™
Vascular Prosthesis is incorporated into the cuff structure of the On-X valve
to create the ascending aortic prosthesis. Orientation reference marks are
provided on the exterior of the graft to aid implantation.
The On-X®Prosthetic Heart Valve is a bileaflet mechanical heart valve,
which consists of an orifice and two leaflets. The orifice inflow area has a
flared inlet designed to reduce flow turbulence, and the outflow rim con-
sists of leaflet guards designed to protect the leaflets while in the closed
position. The leaflets rotate around tabs located within the inner circumfer-
ence of the orifice ring. In the closed position, each leaflet forms a nominal
angle of 40º relative to the plane of the orifice. In the open position, the
plane of each leaflet forms a nominal angle of 90º relative to the plane of
the orifice. The leaflets have a travel arc of 50º to the closed position. The
orifice is composed of a graphite substrate coated with On-X®Carbon,
a pure unalloyed form of pyrolytic carbon. The leaflets consist of On-X®
Carbon deposited on graphite substrates, which are impregnated with 10
weight% tungsten to provide radiopacity. The sewing cuff is constructed of
polytetrafluoroethylene (PTFE) fabric mounted on the orifice using titanium
retaining rings and 5-0 polyester suture material. This form of sewing cuff
attachment to the orifice allows for rotation of the sewing cuff in situ during
implantation.
The Gelweave Valsalva™ Vascular Prosthesis is a woven polyester prosthe-
sis designed to mimic the geometry of the sinus of Valsalva. The graft is
impregnated with an absorbable protein (modified mammalian gelatin) to
eliminate preclotting of the graft in surgery. The gelatin has been cross-
linked to a set level to control its rate of removal. After implant, the gelatin
is hydrolyzed within approximately 14 days and is replaced by normal tissue
incorporation. Gelatin is a non-antigenic and non-toxic protein as reflected
in its use as a safe plasma expander.
The gelatin used in the graft is manufactured from animals native to and
exclusively raised in Australia.
2. INDICATIONS
The On-X®Ascending Aortic Prosthesis is indicated for the replacement of
a diseased, damaged, or malfunctioning native or prosthetic heart valve in
the aortic position in cases that involve an ascending aortic aneurysm or
other associated aortic disease.
3. CONTRAINDICATIONS
The On-X®Ascending Aortic Prosthesis is contraindicated for patients
unable to tolerate anticoagulation therapy or who exhibit sensitivity to
polyester or materials of bovine origin.

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4. WARNINGS AND PRECAUTIONS
4.1 Warnings
USE ONLY AS INDICATED (see section 2).
FOR SINGLE USE ONLY
DO NOT use the On-X®Ascending Aortic Prosthesis if:
• the prosthesis has been dropped, damaged, or mishandled in any way;
• the expiration date has elapsed;
• the tamper evident seals are broken;
• package damage is evident;
• the serial number tag does not match the serial number on the
container label.
DO NOT pass a catheter, surgical instrument, or transvenous pacing lead
through the aortic prosthetic heart valve as this may cause valvular insuf-
ficiency, leaflet damage, leaflet dislodgment, and/or catheter/ instrument/
lead entrapment.
DO NOT re-sterilize the On-X®Ascending Aortic Prosthesis.
DO NOT use the On-X®Ascending Aortic Prosthesis if the expiration date
has elapsed. If a prosthesis is unused, its foil pouch and sealed plastic tray
container is undamaged, and the sterility expiration date has passed, the
prosthesis should be returned to On-X LTI.
DO NOT use the On-X®Ascending Aortic Prosthesis if either tamper evi-
dent label at each end of the outer box has been broken or is damaged. If
either tamper evident label has been broken or is damaged, use another
prosthesis and arrange to return the unused product to On-X LTI.
DO NOT use the On-X®Ascending Aortic Prosthesis if the protective foil
pouch is damaged or if the prosthesis has been dropped, damaged, or
mishandled in any way. If any damage is found, use another prosthesis and
arrange to return the unused product to On-X LTI.
DO NOT preclot the Gelweave Valsalva™ Vascular Prosthesis.
DO NOT exert excessive force on the valve components or the graft.
DO NOT attempt to re-insert the holder handle into the prosthesis (valve)
once it has been released from the prosthesis. Doing so could damage the
valve and cause catastrophic failure of the valve or harm to the patient.
DO NOT use the holder handle to rotate the valve once implanted.
DO NOT attempt to disassemble the holder handle. A small spring pro-
tected inside the assembled holder handle could escape and be unnoticed
in the sterile field.
ONCE the foil package is opened, the prosthesis must be implanted within
24 hours. If the plastic trays with sealed Tyvek®lids are not damaged, steril-
ity of the prosthesis is maintained and the sealed tray set can remain out
of the foil pouch for up to 24 hours. If the prosthesis is not implanted within
24 hours of opening the foil pouch, arrange return of the prosthesis to
On-X LTI.

On-X®Ascending Aortic Prosthesis IFU 6
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TEST the leaflet mobility only with the On-X leaflet probe.
All accessory instruments must be cleaned and sterilized prior to use
according to the instructions provided separately with the instruments.
USE ONLY the On-X rotator to rotate the valve in situ. Use only the cor-
respondingly sized rotator. Use of the wrong size rotator could damage
the valve.
DO NOT use the On-X®Ascending Aortic Prosthesis if the inner tray lid
is damaged. If the inner tray lid is damaged, use another prosthesis and
arrange to return the unused product to On-X LTI
DO NOT use the On-X®Ascending Aortic Prosthesis if the valve does not
rotate easily. Use another prosthesis and arrange to return the unused
product to On-X LTI.
DO NOT use the On-X®Ascending Aortic Prosthesis if the serial number
tag does not match the container label. Use another prosthesis and arrange
to return the unused product to On-X LTI.
DO NOT size the sewing cuff of the size 19 mm through 25 mm aortic valve
to fit within the annulus. Size 27/29 mm aortic valves are designed to be
placed in an intra-annular position and have a replica sizer to mimic this
placement.
4.2 Precautions
CAUTION: Federal (USA) law restricts this device to sale, distribution and
use by or on the order of a physician.
Handle the prosthesis with On-X Valve Instruments and the provided prod-
uct handle. Only On-X valve sizers should be used during the selection of
the prosthesis size; other sizers may result in improper prosthesis selection.
Avoid contacting the carbon surfaces of the valve with gloved fingers or any
metallic or abrasive instruments as they may cause damage to the valve sur-
face not seen with the unaided eye that may lead to accelerated valve struc-
tural dysfunction, leaflet escape, or serve as a nidus for thrombus formation.
No resistance should be experienced when inserting the rotator. If resis-
tance is encountered, stop, remove, and realign the rotator before attempt-
ing to insert the rotator again. Retest leaflet motion after rotation. If free
leaflet motion cannot be achieved, remove the prosthesis.
Clamping may damage any vascular graft. Handling of the graft must be
gentle and minimized in order to prevent loss of gelatin coating.
Excessive tension on the graft should be avoided.
The use of round taper point needles minimizes graft damage. When de-
airing through the graft, a 19-gauge needle is usually sufficient. Cutting
point needles should be avoided to prevent damage.
Gelweave Valsalva™ Vascular Prosthesis has a woven structure and there-
fore should be cut with a cautery to minimize fraying. Use of the cautery for
any sealed graft can cause burning. Immersion of the graft in saline prior to
use of the cautery will prevent focal burning. Immersion of the ascending
aortic prosthesis should be no longer than 5 minutes. The prosthesis should
not be allowed to dry out after soaking.

On-X®Ascending Aortic Prosthesis IFU7
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Do not attempt to rotate the valve if any significant resistance to rotation
is encountered and only use the valve rotator attached to the instrument
handle to rotate the valve. The torque required to rotate the valve in situ
should be about the same as that required when testing rotation before
implantation. If noticeably greater torque is required to rotate, stop
attempting rotation. If rotation is necessary and cannot be performed,
remove the prosthesis.
Use only On-X valve sizers when sizing the annulus. Sizers contain cylindri-
cal, conical, and aortic replica ends.
5. POTENTIAL ADVERSE EVENTS
Adverse events potentially associated with the use of aortic valved grafts
include, but are not limited to:
• angina
• cardiac arrhythmia
• endocarditis
• heart failure
• hemolysis
• hemolytic anemia
• hemorrhage
• myocardial infarction
• valve leaflet entrapment
(impingement)
• valve nonstructural dysfunction
• valve pannus overgrowth
• valve perivalvular leak
• valve regurgitation
• valve structural dysfunction
• valve thrombosis
• thromboembolism
• stroke
• graft infection
• false aneurysm, aneurysm
• secondary fistula formation
• graft occlusion or kinking
• excessive blood loss through
the graft
It is possible that these complications could lead to:
• reoperation
• explantation
• permanent disability
• death
Mechanical prosthetic heart valves produce audible sounds as a normal
function of their operation. In some patients, these sounds may be objec-
tionable.
Risk of Re-use:
In accordance with the EU Medical Device Directive, 93/42/EEC, Annex I,
Section 13.6h, the device manufacturer must provide information on risks
associated with re-use of a single use device. Therefore, the following state-
ment is provided:
Risks of re-using the AAP device:
The implanted graft is customized to the patient. In addition to the risks
listed in this section, re-use in another patient, would risk exsanguination.
Additional risks are bloodborne pathogens, and bacterial infection.
6. INDIVIDUALIZATION OF TREATMENT
Adequate anticoagulant or anticoagulant/antiplatelet therapy should be
administered postoperatively. Selection of an anticoagulant or anticoagu-
lant/antiplatelet regimen is based on the particular needs of the patient, the
clinical situation and established professional guidelines.

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6.1 Specific Patient Population
The safety and effectiveness of the On-X®Ascending Aortic Prosthesis has
not been established for the following specific populations because it has
not been studied in these populations:
• patients who are pregnant;
• nursing mothers;
• patients with chronic endocarditis;
• patients requiring pulmonary root replacement.
7. PATIENT COUNSELING
• Prophylactic antibiotic treatment must be provided to all patients with
prosthetic valves undergoing dental procedures or other potentially
bacteremic procedures.
• Patients require anticoagulation or anticoagulant/antiplatelet therapy.
• Patients should be encouraged to complete the Patient Record Card
provided with the prosthesis and carry it with them at all times.
• Patients should be informed of the use of bovine-derived materials
within this device in advance of procedure.
8. HOW SUPPLIED
8.1 Available Models and Sizes
The On-X®Ascending Aortic Prosthesis is available in sizes 19, 21, 23, 25,
and 27/29 mm. The symbol SZ mm on the box and container labels refers
to the tissue annulus diameter of the valve in millimeters. A circular symbol
representing actual graft diameter appears on each box end label. See
Table 1 for all product specifications.
8.2 Ascending Aortic Prosthesis Holder Handle
The On-X®Ascending Aortic Prosthesis is supplied mounted on a plastic
extended holder handle with spring action for one time use. This holder
handle (Figure 2) facilitates positioning the prosthesis during surgery.
The prosthesis can be released from the holder by depressing the central
plunger.
WARNING: Do not attempt to re-insert the holder handle into the pros-
thesis (valve) once it has been released from the prosthesis. Doing so could
damage the valve and cause catastrophic failure of the valve or harm to the
patient.
WARNING: Do not attempt to disassemble the holder handle. A small
spring protected inside the assembled holder handle could escape and be
unnoticed in the sterile field.
8.3 Packaging
The On-X®Ascending Aortic Prosthesis is provided sterile, mounted on a
holder, in inner and outer plastic trays enclosed in a foil pouch that serves
as a vapor barrier and preserves optimal prosthesis characteristics. The foil

On-X®Ascending Aortic Prosthesis IFU9
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pouch and outer tray are not sterile. Tyvek®seals on the inner and outer
trays must be intact. Any damage to the trays renders the prosthesis non-
sterile. In the event of damage to the primary packaging, the product must
not be used and should be returned to On-X LTI. The packaging consists
of the following items:
• Outer box with labeling
• Plastic prosthesis tray x 2,
inner and outer
• Plastic extended valve holder
with handle
• Prosthesis serial number tag
• Silica gel sachet
• Foil pouch
• May contain Instructions for Use
booklet
• Patient record card
• Instructional card, complete
with Courtesy Labels, used for
accessing: 1) Electronic Implant
Registration and 2) Electronic
Instructions for Use
Instruments for implantation of the On-X®Ascending Aortic Prosthesis are
supplied separately, NON-STERILE, and must be cleaned and sterilized prior
to use as outlined in the Instructions for Use provided with the instruments.
8.4 Storage
The On-X®Ascending Aortic Prosthesis is provided sterile. The sterility
expiration date of the device is recorded on the outer package labeling.
Appropriate inventory control should be maintained so that prostheses
with earlier expiration dates are preferentially implanted and expiration is
avoided. To protect the prosthesis, it should be stored in its outer box until
used. The storage environment should be clean, cool, and dry at a tempera-
ture not less than 0˚C (32˚ F) or higher than 35˚C (95˚ F).
WARNING: Once the foil package containing the sealed plastic tray set and
prosthesis is opened, the prosthesis must be implanted within 24 hours. If
the plastic trays with sealed Tyvek®lids are not damaged, sterility of the
prosthesis is maintained and the sealed tray set can remain out of the foil
pouch for up to 24 hours. If the prosthesis is not used within 24 hours,
contact On-X LTI Customer Service ([phone] or [email protected]) to
arrange return of the prosthesis.
8.5 Accessories
The On-X®Ascending Aortic Prosthesis (valve) is designed to be used only
with On-X instruments. The instruments, supplied separately, are provided
as a set, which includes sizers, rotators, an instrument handle, and a leaflet
probe. The instruments are reusable. See the On-X Prosthetic Heart Valve
Instruments Instructions for Use for complete descriptions of instruments,
their use and reprocessing.
Replica Sizers
Aortic replica sizers are provided for all aortic valve sizes (Figure 3). They
are used to assure fit of the aortic valve without obstruction of the coronary
arteries. The size 19 through 25 aortic replica sizer shape is intended to
model supra-annular positioning of the valve sewing ring. Size 27/29 aortic
replica sizer is intended to model intra-annular positioning.
Instrument Handle
The instrument handle is comprised of a grip, a bendable stem and a tip
that facilitates holding the rotator during surgery (Figure 4).

On-X®Ascending Aortic Prosthesis IFU 10
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Rotator
The valve rotator (Figure 5) is used for reorienting an in situ valve after
the conduit is cut to length. The rotator consists of a plastic head with a
centrally located leaflet probe and a slot for connection to the instrument
handle. To attach the rotator to the instrument handle, insert the instrument
handle tip directly into the slot on the end of the rotator handle. The rotator
snaps into place after the application of a light insertion force.
Leaflet Probe
The leaflet probe (Figure 6) is a flexible rod with tapered ends. The leaflet
probe may be used to gently move the leaflets to verify that they open and
close freely.
9. DIRECTIONS FOR USE
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if:
• the prosthesis has been dropped, damaged, or mishandled in
any way;
• the expiration date has elapsed;
• the tamper evident seal is broken;
• package damage is evident;
• the serial number tag does not match the serial number on the
container label.
9.1 Physician Training
The techniques for implanting the On-X®Ascending Aortic Prosthesis are
similar to those used for any ascending aortic prosthesis. Trained cardiovas-
cular surgeons will be familiar with these techniques.
9.2 Sterilization and Re-sterilization
The On-X®Ascending Aortic Prosthesis is provided sterile. If the sterility
expiration date has passed, or if upon removal from the outer box, the
foil pouch is punctured or the sterility barriers of the sealed plastic trays
inside the foil pouch are compromised, do not use the prosthesis, contact
On-X LTI Customer Service ([phone] or [email protected]) to arrange
return of the prosthesis.
WARNING: Once the foil package is opened, the prosthesis must be
implanted within 24 hours. If the plastic trays with sealed Tyvek®lids are
not damaged, sterility of the prosthesis is maintained and the sealed tray
set can remain out of the foil pouch for up to 24 hours. If the prosthesis is
not implanted within 24 hours of opening the foil pouch, contact On-X LTI
Customer Service ([phone] or [email protected]) to arrange return of
the prosthesis.
WARNING: Do not re-sterilize the On-X®Ascending Aortic Prosthesis.
9.3 Handling and Preparation Instructions
CAUTON: Handle the prosthesis only with On-X LTI Instruments. Only On-X
valve sizers should be used during the selection of the prosthesis size; other
sizers may result in improper prosthesis selection.

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CAUTION: Avoid contacting the carbon surfaces of the valve with gloved
fingers or any metallic or abrasive instruments as they may cause damage
to the valve surface not seen with the unaided eye that may lead to accel-
erated valve structural dysfunction, leaflet escape, or serve as a nidus for
thrombus formation.
CAUTION: Avoid damaging the prosthesis through the application of
excessive force to the valve orifice or leaflets or to the graft.
Circulating Nurse
1. Check the expiration date on the outer box.
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if the
expiration date has elapsed. If a prosthesis is unused, its foil pouch and
sealed plastic tray container is undamaged, and the sterility expiration
date has passed, the prosthesis should be returned to On-X LTI.
2. Check the labels at each end of the box for integrity.
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if either
tamper evident label at each end of the outer box has been broken
or is damaged. If either tamper evident label has been broken or is
damaged, use another prosthesis and arrange for return of the unused
product through On-X LTI Customer Service ([phone] or
[email protected]).
3. Open the outer box and remove the protective foil pouch containing
the prosthesis and package inserts. Inspect the foil pouch for damage.
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if
the protective foil pouch is damaged or if the prosthesis has been
dropped, damaged, or mishandled in any way. If any damage is found,
use another prosthesis and arrange for return of the unused product
through On-X LTI Customer Service ([phone] or [email protected]).
4. Complete electronic implant registration on www.onxlti.com/
implantregistration as completely as local law allows and as soon
as possible. This allows the patient to be entered into the tracking
database, which could be important for future notices regarding the
prosthesis. Give the patient record card to the patient.
5. Open the foil pouch by tearing it at one of the notches on either side of
the indicated tear line. Illustrations for opening the foil pouch, removing
and opening the outer tray, introducing the inner tray into the sterile
field and opening the inner tray are given on the foil pouch.
6. Open the outer tray lid by grasping the pull tab marked on the corner
of the outer lid and pulling the lid in the direction of the arrow. (Refer to
the illustration on the foil pouch.)
7. The inner container can be placed in the sterile field by gently inverting
the outer container slightly above the sterile field and allowing the inner
container to slip out into the sterile field. (Refer to the illustration on the
foil pouch.)

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Scrub Nurse/Surgeon:
8. The scrub nurse may open the sterile inner tray by grasping the pull tab
marked on the corner of the inner lid and pulling toward the direction
of the arrow. (Refer to the illustration on the foil pouch.) The prosthesis
inner container is then placed onto the instrument tray.
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if the
inner tray lid is damaged. If the inner tray lid is damaged, use another
prosthesis and arrange for return of the unused product through
On-X LTI Customer Service ([phone] or [email protected]).
9. To remove the prosthesis from the inner tray, stabilize the tray on the
sterile field with one hand. With the other hand, insert the fingers
around the holder handle end and gently lift upward with enough force
to release it from the tray (Figure 7, and the illustration on the inner tray
lid).
10. To test rotation, carefully grasp the sewing cuff with a gloved hand
using a light grip and gently turn the top of the holder handle in either
direction. The valve should easily rotate within the sewing cuff.
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if
the valve does not rotate easily. Use another prosthesis and arrange
for return of the unused product through On-X LTI Customer Service
([phone] or [email protected]).
11. Check the serial number tag against the label on the outer tray.
WARNING: Do not use the On-X®Ascending Aortic Prosthesis if the
serial number tag does not match the container label. Use another
prosthesis and arrange for return of the unused product through
On-X LTI Customer Service ([phone] or [email protected]).
12. Remove the serial number tag by cutting the suture that holds it on
the prosthesis. If desired, the tag can be used to check for sterility
by standard culture techniques immediately after it is removed. The
prosthesis is now ready for implant.
9.4 Device Implantation
WARNING: All accessory instruments must be cleaned and sterilized prior
to use according to the On-X Instrumentation Instructions for Use provided
separately with the instruments.
Sizing
CAUTION: Use only On-X valve sizers when sizing the annulus. Sizers con-
tain cylindrical, conical, and aortic replica ends.
Cylindrical sizers correspond to valve sizes 19 mm through 25 mm. Conical
sizers correspond to valve size 27/29 mm. The correct valve size is deter-
mined by obtaining a comfortable, not tight, fit of the sizer within the
annulus. When a comfortable fit is found, the corresponding valve size is
signified by the identification on the sizer.

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Aortic replica sizers are provided for all aortic valve sizes. For size 19 mm
through 25 mm aortic valves, the aortic replica sizers are used to verify that
the aortic valve can be properly seated in the annulus and that the coronary
arteries remain unobstructed. Size 19 mm through 25 mm aortic valves are
designed to fit within the annulus at implant such that the exposed carbon
flare rests in the annulus and the sewing ring is intra-supra annular.
WARNING: Do not size the sewing cuff of the size 19 mm through 25
mm aortic valve to fit within the annulus. Size 27/29 mm aortic valves are
designed to be placed in an intra-annular position and have a replica sizer
to mimic this placement.
9.5 Valve Suturing Techniques
Valve suturing techniques vary according to the preferences of the implant-
ing surgeon and patient condition. The aortic valve is designed to have
the tissue annulus about the orifice flare. The general consensus among
surgeons is that a non-everting interrupted mattress suture technique, with
or without pledgets, provides the best conformation of the valve annulus to
the outer surface of the flare.
Sutures should be passed through the midpoint of the sewing cuff. This
allows the sewing cuff to remain flexible and conform to the annulus. It also
prevents the suture needle from contacting the titanium rings that lie within
the sewing cuff. The orientation marks on the sewing cuff may be used to
aid in suture placement.
When all sutures are in place, the prosthesis is advanced into the annulus
and the sutures are tied down. It is suggested that the first 3 knots be
tied equidistant to one another and midway between the commissures to
stabilize the valve in the annulus. The holder handle is removed from the
valve by carefully depressing the plunger in the holder handle as shown in
Figure 8, then gently lifting the holder handle out of the valve/prosthesis.
WARNING: Do not attempt to reinsert the valve holder handle into the
valve once it has been removed. Doing so could damage the valve and
cause catastrophic failure of the valve or harm to the patient.
9.6 Graft Length and Suturing
The graft portion of the prosthesis may be trimmed at any time during the
implant procedure to the appropriate length.
CAUTION: Clamping may damage any vascular graft. Handling of the graft
must be gentle and minimized in order to prevent loss of gelatin coating.
CAUTION: Excessive tension on the graft should be avoided.
CAUTION: The use of round taper point needles minimizes graft damage.
When de-airing through the graft, a 19-gauge needle is usually sufficient.
Cutting point needles should be avoided to prevent damage.

On-X®Ascending Aortic Prosthesis IFU 14
English
CAUTION: Gelweave Valsalva™ Vascular Prosthesis is a woven structure
and therefore should be cut with a cautery to minimize fraying. Immersion
of the graft portion of the prosthesis in saline immediately prior to use will
prevent focal burning which may result during cauterization for coronary
ostia or to trim the graft. The prosthesis should be immersed in saline for no
longer than 5 minutes and should not be allowed to dry out after soaking.
9.7 Leaflet Motion Assessment and Valve Rotation
Leaflet Motion Testing
Once the prosthesis is in place, free motion of the leaflets must be tested.
To test leaflet mobility, use the leaflet probe to gently move the leaflets to
verify that they open and close freely.
WARNING: Test the leaflet mobility only with the On-X LTI leaflet probe.
Rotation
If the leaflets do not move freely, gently rotate the valve in either direction
until it reaches a position where leaflet interference is not encountered.
The rotator may be used with or without the instrument handle attached. As
needed, attach the instrument handle to the rotator by inserting the instru-
ment handle tip into the slot on the end of the rotator handle until it snaps
firmly into position. With the rotator leaflet probe between the leaflets and
the cross-bar aligned with the leaflet pivot axis of the valve, carefully insert
the valve rotator into the valve until it seats easily in place.
CAUTION: Do not attempt to rotate the valve if any significant resistance
to rotation is encountered. The torque required to rotate the valve in situ
should be about the same as that required when testing rotation before
implantation. If noticeably greater torque is required to rotate, stop
attempting rotation. If rotation is necessary and cannot be performed,
remove the prosthesis.
WARNING: Do not use the holder handle to rotate the valve once implant-
ed.
WARNING: Use only the On-X rotator to rotate the valve in situ. Use only
the correspondingly sized rotator. Use of the wrong size rotator could dam-
age the valve.
CAUTION: No resistance should be experienced when inserting the rotator.
If resistance is encountered, stop, remove, and realign the rotator before
attempting to insert the rotator again. Retest leaflet motion after rotation. If
free leaflet motion cannot be achieved, remove the prosthesis.
9.8 Valve Orientation
Based on clinical studies, there is no preferred orientation for the On-X®
Prosthetic Heart Valve in the On-X®Ascending Aortic Prosthesis.

On-X®Ascending Aortic Prosthesis IFU15
English
10. POSTOPERATIVE INFORMATION
10.1 Magnetic Resonance Imaging (MRI) Compatibility
MR Conditional
The On-X Prosthetic Heart Valve, Conform-X Mitral Heart Valve
Prosthesis, Size 25-33*, was determined to be MR-conditional accord-
ing to the terminology specified in the American Society for Testing and
Materials (ASTM) International, Designation: F2503-08. Standard Practice
for Marking Medical Devices and Other Items for Safety in the Magnetic
Resonance Environment. ASTM International, 100 Barr Harbor Drive, PO
Box C700, West Conshohocken, Pennsylvania.
Non-clinical testing demonstrated that the On-X Conform-X Mitral Heart
Valve Prosthesis, Size 25-33, is MR Conditional. A patient with this device
can be scanned safely immediately after placement under the following
conditions:
Static Magnetic Field
• Static magnetic field of 3-Tesla or less
• Maximum spatial gradient magnetic field of 720-Gauss/cm or less
MRI-Related Heating
In non-clinical testing, the On-X Prosthetic Heart Valve, Conform-X Mitral
Heart Valve Prosthesis, Size 25-33, produced the following temperature
rise during MRI performed for 15-min of scanning (i.e., per pulse sequence)
in the 3-Tesla (3-Tesla/128-MHz, Excite, HDx, Software 14X.M5, General
Electric Healthcare, Milwaukee, WI) MR system:
Highest temperature change +1.6˚C
Therefore, the MRI-related heating experiments for the On-X Conform-X
Mitral Heart Valve Prosthesis, Size 25-33, at 3-Tesla, using a transmit/receive
RF body coil at an MR system reported whole body averaged SAR of 2.9-W/
kg (i.e., associated with a calorimetry measured whole body averaged value
of 2.7-W/kg), indicated that the greatest amount of heating that occurred in
association with these specific conditions was equal to or less than +1.6˚C.
Artifact Information
MR image quality may be compromised if the area of interest is in the exact
same area or relatively close to the position of the On-X Conform-X Mitral
Heart Valve Prosthesis, Size 25-33. Therefore, optimization of MR imaging
parameters to compensate for the presence of this device may be neces-
sary.
Pulse Sequence T1-SE T1-SE GRE GRE
Signal Void Size 1,090-mm2686-mm21,478-mm21,014-mm2
Plane Orientation Parallel Perpendicular Parallel Perpendicular
*The MRI findings apply to this specific largest heart valve prosthesis and all
other smaller sizes which are made from similar materials.

On-X®Ascending Aortic Prosthesis IFU 16
English
10.2 Returned Goods
Prior authorization from On-X LTI Customer Service is required for the
return of any product. For any questions regarding the valve or for return
authorization, please contact Customer Service at [phone] or
[email protected].
Licensed under U.S. Patent Nos. 5,137,532; 5,545,216; 5,772,694; 5,908,452;
5,677,061; 6,096,075; 5,641,324; and foreign counterpart patents.
11. PATIENT INFORMATION
11.1 Patient Registration
In each On-X® Ascending Aortic Prosthesis package, an Instructional
Card, complete with Courtesy Labels, used for accessing the Electronic
Implant Registration and Electronic Instructions for Use is included. On-X
LTI requests that the Electronic Implant Registration be completed imme-
diately.
On-X LTI will use these data for notification purposes and to help with inven-
tory restocking in the hospital. All patient information remains strictly con-
fidential, and the release of patient identifying information can be refused
if allowed by local law.
11.2 Patient Record Card
A Patient Record Card is provided with the prosthesis. The card should
be given to the patient (or placed in the patient record to be given to the
patient). Patients should be encouraged to complete the card and carry it
with them at all times.
12. DISCLAIMER OF WARRANTIES
Because of the complications listed previously that may occur with the use
of any ascending aortic prosthesis and the possibilities of damage, also
noted previously, before, during or after implantation, On-X LTI warrants
only that the product shall conform to On-X LTI’s standard specifications. No
other warranty is made by On-X LTI concerning the function of the product
in use, and On-X LTI assumes no risk whatsoever as to the results of the use
of this product. The entire risk with use of the product is that of the buyer.
On-X LTI disclaims all other warranties, respecting the product, expressed
or implied, including but not limited to those related to the product’s mer-
chantability or fitness for a particular purpose. On-X LTI shall not be liable
for any direct, special, consequential or incidental loss, damage or expense
related to the use of the product. No person has any authority to alter any
of these conditions or to bind On-X LTI to any additional responsibility or
warranty in connection with the use of the product.

Инструкции за употреба за Протеза на възходящата аорта On-X®1
Български
СЪДЪРЖАНИЕ
1. ОПИСАНИЕ НА ИЗДЕЛИЕТО...............................................................................................3
2. ПОКАЗАНИЯ.....................................................................................................................3
3. ПРОТИВОПОКАЗАНИЯ......................................................................................................3
4. ПРЕДУПРЕЖДЕНИЯ И ПРЕДПАЗНИ МЕРКИ.......................................................................4
4.1 Предупреждения.............................................................................................................................. 4
4.2 Предпазни мерки ............................................................................................................................. 5
5. ПОТЕНЦИАЛНИ НЕЖЕЛАНИ РЕАКЦИИ ..............................................................................6
6. ИНДИВИДУАЛИЗАЦИЯ НА ЛЕЧЕНИЕТО.............................................................................7
6.1 Конкретна група пациенти............................................................................................................... 7
7. КОНСУЛТИРАНЕ НА ПАЦИЕНТИТЕ .....................................................................................7
8. НАЧИН НА ОТПУСКАНЕ.....................................................................................................7
8.1 Налични модели и размери............................................................................................................. 7
8.2 Дръжка на носача на протезата на възходящата аорта ................................................................ 7
8.3 Опаковка ........................................................................................................................................... 7
8.4 Съхранение........................................................................................................................................ 8
8.5 Принадлежности............................................................................................................................... 8
9. УКАЗАНИЯ ЗА УПОТРЕБА ..................................................................................................9
9.1 Обучение на лекарите ...................................................................................................................... 9
9.2 Стерилизация и рестерилизация..................................................................................................... 9
9.3 Инструкции за работа и подготовка................................................................................................ 9
9.4 Имплантация на изделието............................................................................................................ 11
9.5 Клапни шевни техники................................................................................................................... 11
9.6 Дължина на графта и зашиване .................................................................................................... 12
9.7 Оценка на движението на клапните платна и ротация на клапата............................................. 12
9.8 Ориентация на клапата .................................................................................................................. 13
10. ПОСТОПЕРАТИВНА ИНФОРМАЦИЯ................................................................................ 13
10.1 Съвместимост с ядрено-магнитен резонанс (ЯМР).................................................................... 13
10.2 Върнати продукти......................................................................................................................... 14
11. ИНФОРМАЦИЯ ЗА ПАЦИЕНТА .......................................................................................14
11.1 Регистрация на пациента ............................................................................................................. 14
11.2 Медицинска карта на пациента................................................................................................... 14
12. ОТКАЗ ОТ ГАРАНЦИИ ....................................................................................................15

Инструкции за употреба за Протеза на възходящата аорта On-X® 2
Български
ФИГУРИ И ТАБЛИЦИ........................................................................................................ 442
Фигура 1. Протеза на възходящата аорта On-X® Ascending Aortic Prosthesis.................................. 442
Фигура 2. Протеза на възходящата аорта On-X® Ascending Aortic Prosthesis със
сглобката на дръжката на носача...................................................................................................... 442
Фигура 3. Оразмерител с аналог на импланта ................................................................................. 443
Фигура 4. Дръжка на инструмента.................................................................................................... 443
Фигура 5. Клапен ротатор................................................................................................................... 443
Фигура 6. Сонда за платна.................................................................................................................. 443
Фигура 7. Изваждане на протезата от вътрешната опаковка ......................................................... 443
Фигура 8. Снемане на дръжката на носача от протезата................................................................. 444
Таблица 1. Спецификации на протезата на възходящата аорта On-X Ascending
Aortic Prosthesis (mm)......................................................................................................................... 445
Таблица 2. Определения..................................................................................................................... 446

Инструкции за употреба за Протеза на възходящата аорта On-X®3
Български
Моля, отбележете: Всички фигури и таблици са представени в последните страници на тази
брошура. Моля, направете справка в последните страници за илюстрации и данни.
1. ОПИСАНИЕ НА ИЗДЕЛИЕТО
Произведена от фирмата On-X Life Technologies, Inc.TM (On-X LTI), протезата на възходящата аорта On-X®
Ascending Aortic Prosthesis комбинира сърдечната клапна протеза On-X® Prosthetic Heart Valve и съдова-
та протеза GelweaveValsalvaTM Vascular Prosthesis (Фигура 1). Протезата се предлага с размери 19, 21, 23,
25 и 27/29 mm. Съдовата протеза Gelweave Valsalva™Vascular Prosthesis е инкорпорирана в структурата
на маншета на клапата On-X, за да се образува протезата на възходяща аорта. От външната страна на
графта са поставени референтни обозначения за ориентация за улесняване на имплантацията.
Сърдечната клапна протеза The On-X® Prosthetic Heart Valve представлява механична сърдечна клапа
с две платна, съставена от орифициум и две платна. Зоната на входящия кръвоток на орифициума
разполага с разширяващ се входен отвор, който е конструиран да намалява турбуленцията на потока,
а венецът от страната на изходящия кръвоток включва ограничители на платната, конструирани за
тяхната защита, докато са в затворено положение. Платната се въртят около петлици, разположени в
рамките на вътрешната обиколка на пръстена на орифициума. В затворено положение всяко платно
образува номинален ъгъл от 40º спрямо равнината на орифициума. В отворено положение равнината
на всяко платно образува номинален ъгъл от 90º спрямо равнината на орифициума. Платната имат
ходова крива от 50º към затвореното положение. Орифициумът е изграден от графитен субстрат с
покритие от On-X® въглерод - чиста, несплавена форма на пиролитичен въглерод. Платната са изгра-
дени от On-X® въглерод, отложен върху графитни субстрати, импрегнирани с 10 тегловни % волфрам
за осигуряване на рентгеноконтрастност. Шевният маншет е изграден от политетрафлуороетиленов
(PTFE) плат, фиксиран към орифициума с помощта на титаниеви задържащи пръстени и 5-0 поли-
естерен шевен материал. Този начин на фиксиране на шевния маншет към орифициума позволява
неговата ротация на място по време на имплантацията.
Съдовата протеза Gelweave Valsalva™ Vascular Prosthesis представлява тъкана полиестерна протеза,
конструирана да наподобява геометрията на синуса на Валсалва. Графтът е импрегниран с резорби-
руем протеин (модифициран желатин от бозайник) за елиминиране на необходимостта от предвари-
телната му тромботизация по време на операцията. Желатинът има омрежена структура до зададено
ниво, за да бъде контролирана скоростта на отстраняването му. След имплантиране желатинът бива
хидролизиран в рамките на приблизително 14 дни и заместен от враснала нормална тъкан. Желатинът
е неантигенен и нетоксичен протеин и това намира отражение в неговата употреба като безопасен
плазмозаместител.
Използваният в графта желатин е произведен от животни, които се срещат и развъждат изключително
в Австралия.
2. ПОКАЗАНИЯ
Протезата на възходящата аорта On-X® Ascending Aortic Prosthesis е показана за замяна на патологично
изменени, увредени или неправилно функциониращи нативни клапи или клапни протези на аортната
клапа в случаи, които включват аневризма на възходяща аорта или друго свързано заболяване на
аортата.
3. ПРОТИВОПОКАЗАНИЯ
Протезата на възходящата аорта On-X® Ascending Aortic Prosthesis е противопоказана при пациенти
с непоносимост към антикоагулантна терапия, или пациенти с чувствителност към полиестер или
материали от говежди произход.