CryoLife HeRo GRAFT Mode D'emploi page 7

26. Utilizing a standard Kelly-Wick tunneler with a 6 mm bullet tip, tunnel from the DPG to the venous incision site.
27. Insert the 6 mm bullet tip into the end of the Venous Outflow Component and pull through the tunnel to the DPG.
28. Remove the 6 mm bullet tip from the Venous Outflow Component.
Caution: DO NOT bend the Venous Outflow Component beyond a 2.5cm diameter anywhere along its length to prevent
kinking.
NOTE: Alternatively, a GORE Tunneler or Bard Bi-Directional Tunneler may be used. Consult manufacturer IFUs for proper
utilization.
IMPLANTING THE ARTERIAL GRAFT COMPONENT
1. Open the Arterial Graft Component using aseptic technique.
2. Make an incision at the selected arterial anastomosis site. Utilizing a standard vessel loop, expose the artery and verify the ID is
greater than 3 mm in size. Verify patency via Doppler or tactile feel.
Caution: Use of the HeRO Graft was clinically studied utilizing the brachial artery. Arterial implantation of the device to
other arteries has NOT been studied and may increase the risk of adverse events not encountered in the clinical
trial. However, identification of an alternative artery with an ID of 3 mm or greater may result in improved blood
flow compared to a brachial artery with an ID of less than 3 mm.
3. Utilizing a standard Kelly-Wick tunneler with a 7 mm bullet tip, follow the previously drawn soft C graft routing path to create a
subcutaneous tunnel from the arterial incision site to the connector incision site at the DPG. Graft routing will vary depending
on patient-specific anatomy.
4. Remove the 7 mm bullet tip from the Kelly-Wick tunneler and reattach the 6 mm bullet tip.
5. Attach the non-connector end of the Arterial Graft Component onto the 6 mm bullet tip and secure a tight connection with a
suture(s).
6. Gently pull the Arterial Graft Component through the tunnel to the arterial incision site. Utilize the markings on the Arterial
Graft Component to verify it has not twisted.
7. Leave approximately 8cm of the Arterial Graft Component exposed at the DPG incision site to facilitate the connection from the
Arterial Graft Component to the Venous Outflow Component.
8. Cut the Arterial Graft Component from the tunneler and use a standard vascular clamp to occlude the Arterial Graft
Component at the anastomosis site.
CONNECTING THE HeRO GRAFT
1. Place a sterile 4x4 gauze pad between the Venous Outflow Component and the DPG incision site to prevent debris from
contaminating the incision.
2. Determine the Venous Outflow Component length required to make the connection to the Arterial Graft Component at the
final DPG location. Utilizing a pair of heavy duty scissors, straight cut the Venous Outflow Component to the desired length
ensuring that the cut is square to the Venous Outflow Component.
Caution: DO NOT test fit the Venous Outflow Component onto the titanium connector as it was designed not to separate
once connected.
3. Press the cut end of the Venous Outflow Component onto the titanium connector. Connecting the two components is done by
grasping the Venous Outflow Component approximately 2cm back from the cut edge and pushing so it slides more easily over
the first barb of the titanium connector. Continue to push the Venous Outflow Component onto the connector until the cut edge
is flush with the silicone sleeve hub past both barbs.
Caution: The HeRO Graft Venous Outflow Component was designed to engage both barbs of the titanium connector
tightly so that the pieces do not separate. If separation is necessary, a new straight cut should be made to the
Venous Outflow Component. The new cut should be near the connector, and special care should be taken when
trimming and removing the excess Venous Outflow Component piece from the connector. Clean the connector
of any material or residue. If damage occurs to the connector during separation, a new Arterial Graft Component
should be used. Use fluoroscopy to recheck radiopaque tip placement after any adjustment is made.
Caution: DO NOT grasp, peel, or otherwise damage the Arterial Graft Component beads as this may adversely impact the
integrity of the graft. It is important during device connection to grasp the silicone sleeve of the Arterial Graft
Component and avoid contact with the beading. Ensure the beading is not crushed or damaged.
Caution: If damage to the beading is noted during implant, a new Arterial Graft Component should be used.
Caution: Damaged or crushed beading may lead to flow disruption within the HeRO Graft, and may contribute to early
device occlusion and/or repeated occlusion.
Caution: Verify the Arterial Graft Component and Venous Outflow Component are fully connected and that no portion of
the titanium connector is exposed. After the connection is made, verify radiopaque tip placement in the mid to
upper right atrium using fluoroscopy.
4. Carefully position the titanium connector in the soft tissue at the DPG. Reposition the Arterial Graft Component from the
arterial end to remove excess material.
5. Remove the clamps at the Venous Outflow Component and arterial anastomosis sites to backbleed the entire HeRO Graft.
ENGLISH
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