PROXIMAL
ANASTOMOSIS SYSTEM
FG-000001
FOR EXPORT ONLY.
NOT FOR SALE OR USE IN THE UNITED STATES.
Caution: This device is
restricted to sale, distribution, and use by or on the order of a
physician.
System Description
The Cardica® PAS-Port® System delivers an Implant designed to create an
anastomosis between a large target vessel (e.g. aorta) and small caliber
conduit (e.g. saphenous vein). The
Implant is a self-closing stainless steel clip that will create a complete
end-to-side anastomosis that is 4.65 mm in internal diameter when deployed and
which is functionally equivalent to a standard hand-sutured anastomosis. The PAS-Port® System is contained in a package that is designed to
facilitate attachment of the conduit to the Implant, as well as to ensure that
the conduit (after attachment to the system and before deployment) is kept
moist and vital.
The PAS-Port® System is comprised of the following components (see Figure
1):
·
Delivery Tool with Guide Clip
·
Poke-Through Tool (2)
·
Pull-Through Tool
·
Cartridge with
Anastomosing Implant
·
Stop Clip
Intended Use
The PAS-Port® System is designed to create an anastomosis between a large
target vessel, such as the aorta, and a conduit, such as a venous conduit.
Indications
The PAS-Port® System is intended to create an everting anastomosis between
the aorta and an autologous vein graft.
Caution: This product has
not been studied in arterial grafts.
Contraindications
1. Do not use this product on target vessels where conventional
surgical anastomoses would typically not be created due to the presence of
palpable disease. Such determination
may also be based upon echocardiographic demonstration of either mural (e.g.
calcification) and/or intimal (e.g. plaque, exudates) disease.
2. Do not use this product on target vessels less than or equal
to 18 mm in outside diameter and with wall thicknesses that would not be
acceptable for a hand-sewn anastomosis.
3. Do not use this product with conduit vessels that would not
typically be used for bypass grafting procedures.
4.
Do not use this product with conduit vessels that have an
outside diameter of less than 4.0 mm or greater than 6.0 mm, or with double
wall thicknesses greater than 1.4 mm.
Precautions
1.
The PAS-Port® System is
designed for a single surgical procedure only.
DO NOT REUSE.
2. The sterile package of the PAS-Port® System should be inspected prior to use. If the sterility or integrity of the package
is suspect or compromised, the product should not be used.
3. No component of the PAS-Port® System should be resterilized.
4. The components of the PAS-Port® System must remain in the package inner tray during conduit
preparation and conduit attachment to the Implant. Do not remove the product from the inner tray until the Cartridge
containing the conduit and Implant is ready for loading into the Delivery Tool,
as described in the Directions for Use section.
5. Do not use the conduit if there are valves or side branches
within 15 mm of the end that will be attached to the Implant.
6. Do not use clips to ligate side branches of the conduit.
7. If the conduit cannot easily be pulled through the Cartridge
using gentle and constant force, it should not be used.
8. If eversion of the conduit over the Implant is only possible
with difficulty due to its small size or lack of elasticity, the conduit should
not be used.
9. Do not contact the sharp point (Auger Tip) at the deployment
end of the Device.
10. The PAS-Port® System should only
be used by physicians who have been adequately trained by Cardica, Inc., or
representatives.
11. The possibility of graft kinking
can be minimized by careful selection of the anastomotic site on the target
vessel, careful determination of appropriate graft length, and placing
individual stay stitches along the course of the graft (see Sections 1.4 and
2.1).
Warnings
1.
The PAS-Port® System creates the hole in the target vessel and completes
the anastomosis automatically. Do not
create a hole in the target vessel prior to using this product.
2.
Do not use blood or glucose containing solutions as a
storage solution for the conduit vessel during preparation for Device
deployment.
3.
The
mean arterial pressure must be at least 50 mmHg at the initiation of Device
deployment.
4.
Coronary
Artery Bypass Surgery has inherent risks associated with the procedure, such as
stenosis and occlusion of the graft, and these risks vary according to each
patient's specific health conditions.
5.
Failure
to follow the directions can potentially result in damage to device components and/or
injury to the patient.
6.
Patients
allergic to stainless steel may suffer an allergic reaction to this implant.
Directions for Use
1.
Harvest the Conduit
1.1.
Harvest the conduit
using standard procedures. Thoroughly
remove connective tissue. Ensure that
side branches are tied with suture not larger than 4-0. Do not use ligation clips to tie the side
branches of the segment being used as the conduit. Avoid excessive lengths of the side branches; the ends of the
branches remaining in the patient may be clipped. Do not occlude (e.g. tie off, etc.) the distal end of the conduit
prior to Device deployment. The distal end of the conduit is defined as the end
that will be anastomosed to the coronary artery.
1.2.
Inflate the conduit with non-cellular physiologic solution to check for leaks and to counter spasm per
standard surgical routine.
1.3.
Use the Cardica® Vein/Aorta Gauge (provided separately) to determine the
adequacy of the conduit vessel. Do not
use conduits that have an outer diameter of less than 4.0 mm or greater than
6.0 mm, or with double wall thickness greater than 1.4 mm.
NOTE: The Cardica® Vein/Aorta
Gauge (VAG) is not intended for accurate measurement of vessel dimensions. All assessments are approximate. Ensure
that there is approximately 15 mm at the end of the conduit that will be
connected to the Implant that is free of valves and side branches. Cleanly cut the conduit at the end that will
be connected to the Implant at approximately a 90° angle, making sure to keep track of the direction of flow
through the conduit.
1.4.
Determine an adequate
length for the conduit. Appropriate conduit length can be
determined by using a string or suture and marking the estimated required
conduit length with clips, then sizing the inflated conduit to match the length
marked on the string or suture. Graft
kinking can be minimized by determining
the correct conduit length while the heart is contracting and fully engorged
with blood.
1.5.
Store the conduit in
a non-cellular physiologic solution
until use.
2. Prepare the Target Vessel
2.1.
Conduit placement
recommendation: For conduits that target the left lateral wall of the heart,
left posterior or left anterior sections of the myocardium, anastomoses should
be placed on the lesser curvature or left lateral wall of the ascending target
vessel or aortic arch. For conduits
that target the right lateral or right posterior surface of the heart,
anastomoses should be placed on the anterior surface of the ascending target
vessel and can be routed to the left of or over the right atrial
appendage. Placement of the PAS-Port® Implant on the right lateral wall of the ascending target
vessel should be avoided due to a higher risk of graft kinking or external
compression. Place individual stay stitches along the course of the graft
as necessary to avoid kinking, which may occur following closure of the chest.
2.2.
Use the Cardica® Vein/Aorta Gauge (provided separately) to determine the
adequacy of the target vessel at the site of the planned proximal
anastomosis. Do not use the PAS-Port® System on target vessels that have an outer diameter of
less than or equal to 18 mm.
2.3.
Palpate the target
vessel to determine that there is an area at least 25 mm in diameter free of
severe alterations and/or disease. The
area where the surgeon is planning to place the proximal anastomosis should be
of sufficient quality to be considered suitable for a hand-sewn anastomosis.
2.4.
Denude the proposed anastomosis site only if there is excessively
thick connective tissue.
3. Open the Package
3.1.
Inspect the sealed
package containing the PAS-Port® System for evidence of damage and inspect the label to
verify that the product expiration date has not passed. If the product is expired, do not use.
3.2.
Retain the Lot Number
and Expiration Date of the PAS-Port System by peeling off the removable Lot
Number and Expiration Date label and affixing it to the patient’s record.
3.3.
Open the package and
discard outer package material.
3.4.
The inner tray and
inner tray lid are sterile and should only be handled in a sterile
fashion. .
3.5.
Remove and discard
the inner tray lid. All components of
the system should remain in their compartments in the inner tray.
4. Load the Conduit into the Cartridge
NOTE: Refer to the PAS-Port® Graphic Instructions for more illustrations.
4.1.
To ensure smooth
loading through the Cartridge, thoroughly wet the conduit and flush the
Cartridge through the rear inlet with non-cellular physiologic solution (see graphic #1 on PAS-Port® Graphic Instructions).
4.2.
Identify the wire hooks at the end of the Pull-Through
Tool. Lay the conduit in the groove in
the inner 
tray
that aligns with the wire hooks.
Place the end of the conduit that will be connected to the Implant
between the wire hooks (see Figure 3 or graphic #2 on PAS-Port® Graphic
Instructions). Squeeze the handle of
the Pull-Through Tool until it is locked in position (see graphic #3 on
PAS-Port® Graphic Instructions). Keep the handle of the Pull-Through Tool firmly seated and
stationary in the tray during actuation to grip
the conduit. Check to ensure that
the wire hooks securely grip the conduit.
4.3.
Pull the Pull-Through Tool with the attached conduit through
the Cartridge. Ensure that the conduit is fed into the Cartridge so that side
branches do not catch on the inlet.
Continue to pull until the conduit exits the Implant end of the
Cartridge. Approximately 8 mm of
conduit should be protruding beyond the Implant tip.
4.4.
NOTE: If the
Pull-Through Tool disengages from the conduit during loading, do the following:
4.4.1.
Pull the Pull-Through
Tool out of the Cartridge.
4.4.2.
If the conduit can be
grasped from the rear inlet end of the Cartridge, carefully pull the end of the
conduit until it is completely removed from the Cartridge. Take care to not tear the conduit.
4.4.2.1.
Squeeze the handle of
the Pull-Through Tool into the locked position so that the wire hooks are
closed together. Carefully insert the
Pull-Through Tool back into the Cartridge through the Implant end. Take great care not to damage the Implant
tines during this process. Unlock the
Pull-Through Tool handle, firmly seat the handle in the tray, and replace the
Stop Clip. Return to Step 4.1.
4.4.3.
If the conduit cannot
be removed using gentle and constant force, or if the conduit is not accessible
from the rear inlet end, the Cartridge must be disassembled.
4.4.3.1.
The long tube
supporting the Implant consists of top and bottom halves that separate
lengthwise. They are attached at the
end holding the Implant. Grasp the tube
with one hand; hold the Cartridge in the other hand and pull until the tube
separates from the Cartridge.
4.4.3.2
Splay the tube’s top
and bottom halves by separating the features that locked the tube into the
Cartridge. Remove the conduit.
4.4.3.3
Dispose of the PAS-Port®
System. Open a new PAS-Port® System to complete the procedure using the retrieved
conduit.
4.5
Note: If
the conduit has inadvertently been pulled too far past the Implant, do not
attempt to pull the conduit back into the Cartridge, as this may damage the
Implant tines. Continue to pull the
conduit through the Cartridge until it is removed. Release the conduit from the Pull-Through Tool and refer to
Section 4.4.2.1 to proceed.
4.6
When the conduit has
been successfully pulled through the Cartridge, cut off the end of the conduit
close to the penetration points of the wire hooks. This can be done without releasing the hooks. Take care that the conduit does not recoil
into the Cartridge upon cutting. Ensure
that any tissue damaged by the wire hooks is removed (see Figure 4 or
graphic #4 on PAS-Port® Graphic Instructions).
The optimal eversion length of the end of the conduit protruding beyond
the Implant tip is between 3 mm to 6 mm.
4.7
Set the Pull-Through
Tool aside. Remove the Stop Clip from
the package and set it aside (see graphic #5 on PAS-Port®
Graphic Instructions).
5. Evert and Poke-Through the Conduit
5.1.
Using two fine-tip
forceps and holding the conduit at two points 180° apart, gently evert the conduit over the Implant, making
sure all nine tines are covered (see Figure 5a and 5b or graphic #6 and #7 on
PAS-Port® Graphic Instructions).
In a successfully everted conduit, the intima shall be visible on the
outer perimeter of the Implant. The
conduit should not be everted less than 2 mm and not more than 5 mm over the
Implant tines (see graphic #8 on PAS-Port®
Graphic Instructions). If
the conduit cannot easily be everted it should not be used even if it is within
the specifications for use with the PAS-Port® System.
5.2.
In order to inspect the eversion, it
may be necessary to remove the Cartridge from the inner tray by carefully
unsnapping the Cartridge from its cradle.
After inspecting the eversion, return the Cartridge to its cradle in the
inner tray and be sure that the components snap into their correct positions.
5.3.
Remove one of the
Poke-Through Tools and place it in the groove in the inner tray that aligns
with the Cartridge, with the small end of the Poke-Through Tool closest to the
Implant (see Figure 6 or graphic #9 on PAS-Port® Graphic
Instructions).
5.4.
While applying
light downward pressure on the grey tube of the Cartridge in the inner tray
with one hand, use the other hand to slide the Poke-Through Tool forward over
the Implant until the Tool reaches a hard stop, then carefully pull it straight
back and remove it (see Figure 7a, and 7b, and 7c or graphic #10 on
PAS-Port® Graphic Instructions).
5.5.
Inspect the Implant
and conduit and ensure the following (see Figure 7a, 7b, and 7c or
graphic #11 on PAS-Port® Graphic Instructions):
5.5.1.
All of the conduit
layers have been pierced by all nine Implant tines. If not, repeat the poke-through process with the second
Poke-Through Tool. Do not reuse a
Poke-Through Tool.
5.5.2.
The conduit remains
everted towards the base of the Implant.
If the conduit has un-everted, use fine tip forceps to re-evert the
conduit, ensuring that the Implant does not get damaged during this process.
5.5.3.
Inspect the Implant
to ensure that all nine tines of the Implant are symmetrical and are not
bent. If a bent tine is evident,
retrieve the conduit and discard the PAS-Port®
System. Retrieve the conduit by loading
the Cartridge into the Delivery Tool and firing the Device in air within the sterile surgical field. Using forceps, pull the conduit from the
Device and place on a sterile surface.
The conduit can then be cut away from the Implant. The conduit may also be removed by
un-everting and pulling the conduit from the Cartridge. Remove any portion of the conduit that may
have been damaged by the tines. Dispose of the
PAS-Port® System.
5.5.4
Fill the reservoir
surrounding the Cartridge with non-cellular physiologic solution to keep the conduit moist and vital until just
before Delivery Tool loading (see graphic #12 on PAS-Port®
Graphic Instructions).
6. Load the Cartridge into the Delivery Tool
6.1.
When the surgeon is
prepared to perform the proximal anastomosis, remove the Cartridge from the
inner tray.
6.2.
Rest the Implant end
of the Cartridge on the Guide Clip and slide the Cartridge forward until the
Cartridge base is seated in the rails of the -Delivery Tool, see Figure 1. Great care should be taken to avoid damaging
the Implant during loading.
6.3.
Remove the Guide Clip
by pulling the tab. (see graphic #13 on PAS-Port®
Graphic Instructions).
6.4.
Firmly grasp the case of the Delivery Tool with one hand and
push the Cartridge forward with the other hand until it locks in place. Complete insertion of the Cartridge can be
verified by hearing an audible "click"; the Knob will also partially
rotate. This step cannot be
reversed. The PAS-Port® System is now ready for deployment.
7. Deploy the Implant
7.1.
Prepare
the target vessel at the site of the intended anastomosis by briefly
cauterizing the connective tissue to the adventitia in a circular area
approximately equal to 4 mm in diameter.
7.2.
The possibility of
graft kinking can be minimized by careful selection of the anastomotic site on
the target vessel (see Section 2.1).
7.3.
Remove the Device
from the inner tray and unlock the Safety Switch by sliding it to the unlocked
position (see Figure 8). The Cartridge
contains a label reminding the user to activate the Safety Switch. (see Figure 9).
NOTE: The Safety
Switch cannot be moved to the unlocked position if the Cartridge is not
properly loaded in the Delivery Tool. Once the Safety Switch has been moved to
the unlocked position, Knob rotation will immediately result in firing of the
cutter.
7.4.
Position the Device at a 90° angle to the surface of the target vessel at the prepared
site for the anastomosis.
7.5.
Pierce the
target vessel with the Auger Tip, see Figure 2. If the Auger Tip does not easily penetrate the target vessel, a
different anastomosis site should be chosen.
7.6.
Ensure there is full contact between the Device and the
surface of the target vessel without compressing or indenting the target
vessel. Do not move the Device laterally
after it has been placed against the target vessel. Do not hover above the
target vessel.
7.7.
To provide visibility
of the deployment process, orient the Device such that the opening at the
deployment end of the Device is facing the surgeon.
7.8.
Ensure that the mean
arterial pressure during deployment is at least 50 mmHg.
7.9.
To complete the anastomosis, turn the Knob in a clockwise
direction until a hard stop is felt. The
label on the Knob includes an indicator that will point at the rear inlet hole
of the Cartridge once a full rotation of the Knob has been completed (see
Figure 10). The tip of the Device should stay in contact with the target vessel
surface during the entire deployment process. The surgeon should ensure that
the Device does not compress or indent the target vessel.
7.10. After the
aortotomy has been created and before the Implant is inserted into the target
vessel, blood will flow freely through the Seal Housing into the surgical
field. The Seal Housing is the clear
plastic casing located within the opening at the Deployment End of the Device.
Use a suction device to clear the surgical field as necessary. If
blood does not enter the Seal Housing or enters the Seal Housing slowly, abort
the deployment and use standard surgical techniques to repair the target vessel
if necessary.
7.11.
After the Knob
reaches the hard stop, slowly lift the Device away from the target vessel. Hold the conduit close to the Implant with
forceps while the Device is being removed to avoid placing tension on the
anastomosis. Take care not to
manipulate the remaining tines when grasping the conduit as they could detach
from the Device. If there is
difficulty removing the Device because the conduit has become dried to the
inside of the Device, wet the conduit and the Device by flushing non-cellular physiologic solution into the inlet hole at the Knob End of the Device.
7.12.
Remove the Device
from the surgical field. Check the
Device to ensure all remaining 9 tines are present.
7.13.
Place an appropriate
clamp on the end of the graft per standard surgical routine.
7.14.
Before closing the
chest: inspect the anastomosis for leaks and to verify that the Implant appears
properly deployed; inspect the amount of tension on the graft after completion
of both the proximal and distal anastomosis with the heart completely engorged
with blood and in its normal position; and place
individual stay stitches along the course of the graft as necessary to avoid
kinking.
7.14.1.
If individual tines of the implant’s outer flange have
deployed correctly, but are not in contact with the connective tissue of the
target vessel, the surgeon should not attempt manual manipulation of the
tines. A purse-string stitch can be
placed around the Implant to further secure attachment to the target vessel
wall.
7.14.2.
If the implant is not fully or correctly deployed the
implant should be removed, see Section 8.2.
8.
Troubleshooting
8.Troubleshooting
8.1 Should anastomotic hemorrhage be observed
following Implant deployment, the surgeon may attempt to obtain hemostasis by
placing a purse-string stitch around the Implant.
8.2
If blood does not
enter the seal housing during device deployment, hemostasis cannot be obtained,
blood does not enter the graft after device deployment, or the implant did not
deploy properly place a side-biting clamp around the Implant, if deemed
appropriate, and remove the Implant by using a needle holder to crush the body
of the Implant towards the center of the Implant. Repair the attempted anastomosis site. Do not use the aortotomy produced by the PAS-PortÔ System for deployment of a new PAS-Port® System.
Packaging/Storage
The PAS-Port® System is provided sterile and is
designed to remain sterile unless the primary packaging seal has been opened or
damaged. Store in a dry, cool place.
Cardica® PAS-PORT®
