![](media/image1.jpeg){width="2.7506944444444446in"
height="1.007638888888889in"}

![](media/image2.jpeg){width="3.2381944444444444in" height="0.90625in"}

#### PROXIMAL ANASTOMOSIS SYSTEM

##### FG-000001

**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):

-   ![](media/image3.png){width="3.3437007874015747in"
    height="2.8751968503937007in"}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).

    ![](media/image4.jpeg){width="5.027165354330709in"
    height="1.0216535433070866in"}

**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.  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.

    2.  Inflate the conduit with non-cellular physiologic solution to
        check for leaks and to counter spasm per standard surgical
        routine.

    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.

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.**

5.  Store the conduit in a non-cellular physiologic solution until use.

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2.  **Prepare the Target Vessel**

    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.  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.

    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.

    4.  Denude the proposed anastomosis site only if there is
        excessively thick connective tissue.

3.  **Open the Package**

    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.

    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.  Open the package and discard outer package material.

    4.  The inner tray and inner tray lid are sterile and should only be
        handled in a sterile fashion. .

    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.

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).

2.  Identify the wire hooks at the end of the Pull-Through Tool. Lay the
    conduit in the groove in the inner
    ![](media/image5.png){width="2.657638888888889in"
    height="2.0in"}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.

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.  *NOTE*: If the Pull-Through Tool disengages from the conduit during
    loading, do the following:

    1.  Pull the Pull-Through Tool out of the Cartridge.

    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.

        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.

    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.

        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.

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        2.  Splay the tube's top and bottom halves by separating the
            features that locked the tube into the Cartridge. Remove the
            conduit.

        3.  Dispose of the PAS**-**Port^®^ System. Open a new
            PAS-Port^®^ System to complete the procedure using the
            retrieved conduit.

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4.  ![](media/image6.png){width="2.5519685039370077in"
    height="1.9165354330708662in"}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.

5.  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.

6.  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).

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5.  **Evert and Poke-Through the Conduit**

    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.**

    2.  ![](media/image7.png){width="2.0543307086614173in"
        height="1.3161417322834645in"}![](media/image8.png){width="2.0456692913385828in"
        height="1.3161417322834645in"}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.

    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).

> ![](media/image9.png){width="5.5in" height="3.5in"}

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.  Inspect the Implant and conduit and ensure the following
    (see Figure 7a, 7b, and 7c or graphic #11 on PAS**-**Port^®^ Graphic
    Instructions):

    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.

> ![](media/image10.png){width="1.396456692913386in"
> height="1.7866141732283465in"}![](media/image11.png){width="2.3244094488188978in"
> height="1.7866141732283465in"}![](media/image12.png){width="1.396456692913386in"
> height="1.7866141732283465in"}

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.

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.

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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).

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6.  **Load the Cartridge into the Delivery Tool**

    1.  When the surgeon is prepared to perform the proximal
        anastomosis, remove the Cartridge from the inner tray.

    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.

    3.  Remove the Guide Clip by pulling the tab. (see graphic #13 on
        PAS**-**Port^®^ Graphic Instructions).

    4.  ![](media/image13.jpeg){width="3.25in"
        height="2.4311023622047245in"}![](media/image14.png){width="1.6307086614173227in"
        height="1.2625984251968505in"}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**

    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.

    2.  The possibility of graft kinking can be minimized by careful
        selection of the anastomotic site on the target vessel (see
        Section 2.1).

    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.

4.  ![](media/image15.wmf){width="1.958267716535433in"
    height="2.1688976377952756in"}Position the Device at a 90° angle to
    the surface of the target vessel at the prepared site for the
    anastomosis.

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.

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.  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.

8.  Ensure that the mean arterial pressure during deployment is at least
    50 mmHg.

9.  ![](media/image16.png){width="1.2192913385826771in"
    height="1.6118110236220473in"}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.

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.

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.

12. Remove the Device from the surgical field. Check the Device to
    ensure all remaining 9 tines are present.

13. Place an appropriate clamp on the end of the graft per standard
    surgical routine.

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.

    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.

    2.  If the implant is not fully or correctly deployed the implant
        should be removed, see Section 8.2.

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7.  **Troubleshooting**

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8.  

> 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.

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-Port
    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**^®^

**[Manufactured in the USA by:]{.underline}**

Cardica, Inc.

900 Saginaw Drive

Redwood City, CA 94063

**[Authorized European Representative:]{.underline}**
![](media/image17.png){width="0.4270833333333333in"
height="0.3020833333333333in"}

MDSS, GmbH

Burckhardstr. 1

30163 Hannover

Germany

> Symbols used:

+----------+--------------------+----------+-------------------------+
| ![]      | > CAUTION          | ![](     | > EXPIRATION DATE:\     |
| (media/i | > STATEMENT:\      | media/im | > Use By YYYY/MM        |
| mage18.p | > See instructions | age20.wm |                         |
| ng){widt | > for use          | f){width |                         |
| h="0.372 |                    | ="0.2993 |                         |
| 91666666 |                    | 05555555 |                         |
| 66667in" |                    | 55555in" |                         |
| height=  |                    | hei      |                         |
| "0.32569 |                    | ght="0.3 |                         |
| 44444444 |                    | 9375in"} |                         |
| 4445in"} |                    |          |                         |
+----------+--------------------+----------+-------------------------+
| ![]      | > DO NOT REUSE:\   |          | > Sterile statement and |
| (media/i | > Single-use       |          | > sterilization method: |
| mage21.w | > device           |          | > Sterilized by         |
| mf){widt |                    |          | > irradiation           |
| h="0.559 |                    |          |                         |
| 72222222 |                    |          |                         |
| 22222in" |                    |          |                         |
| height   |                    |          |                         |
| ="0.5284 |                    |          |                         |
| 72222222 |                    |          |                         |
| 2222in"} |                    |          |                         |
+----------+--------------------+----------+-------------------------+
| ![](me   | > REFERENCE:\      | ![](me   | > LOT NUMBER:\          |
| dia/imag | > Model Number     | dia/imag | > Manufacturing Lot     |
| e22.wmf) |                    | e23.wmf) | > Number                |
+----------+--------------------+----------+-------------------------+

![](media/image24.png)

Universal Product Number BAR CODE: Includes manufacturer and product
number, in HIBC format.

> **Translations: Go to** www.cardica.com/PAS-port/ifu
>
> **Username:** cardica
>
> **Password:** pasport
>
> The Cardica website can be properly viewed with the following
> browsers: Netscape™ and Internet Explorer™ Version 5 or higher. The
> Instructions for Use are available as PDF files that can be viewed
> with Adobe Acrobat Reader™. Adobe Acrobat Reader™ can be downloaded
> free of charge from the Adobe Inc. website
> ([www.adobe.com](http://www.adobe.com/)). Instructions for use must be
> available during surgery.
>
> *Deutsch* Die Anleitung muss während der Operation verfügbar sein.
>
> *French* Le mode d\'emploi doit être disponible pendant la chirurgie.
>
> *Italian* Le istruzioni per l\'uso devono essere disponibili durante
> l\'intervento chirurgico
>
> *Spanish* Las instrucciones de uso deben tenerse a mano durante las
> intervenciones quirúrgicas.

*Swedish* Bruksanvisning måste finnas tillgänglig under kirurgi.

*Dutch* De gebruiksaanwijzing moet tijdens de operatie voorhanden zijn.

*Greek* Οι οδηγίες χρήσης θα πρέπει να είναι διαθέσιμες κατά τη διάρκεια
της επέμβασης.

*Portuguese* As instruções de utilização têm de estar disponíveis
durante a cirurgia.

> *Danish* Brugsanvisningen skal være disponibel under operation.