Merit Medical HERO GRAFT Mode D'emploi page 10

Caution: DO NOT grasp, peel, or otherwise damage the Support Seal as this may adversely impact the integrity of the graft. It is
important during device connection to avoid contact with the Support Seal. Ensure the Support Seal is not crushed or
damaged.
Caution: If damage to the Support Seal is noted during implant, new components should be used.
Caution: A damaged Support Seal may lead to flow disruption within the HeRO Graft, and may contribute to early device occlusion
and/or repeated occlusion.
4. Verify the Venous Outflow Component is fully advanced onto the Adapter and flush with the Adapter shoulder.
5. After the connection is made, verify radiopaque tip placement in the mid to upper right atrium using fluoroscopy.
6. Carefully position the Adapter in the soft tissue at the DPG. Reposition the graft from the arterial end to remove excess material.
7. Remove the clamps at the Venous Outflow Component and arterial anastomosis sites to backbleed the entire HeRO Graft.
8. Reclamp the graft while avoiding the Support Seal.
9. Attach a syringe with heparinized saline to the graft using a syringe adapter. Remove the clamp and flush the entire HeRO Graft. Verify there is no
leakage at the connection sites and reclamp the graft.
Caution: If leakage is observed, check for proper connection. If there is a leak at the Adapter site, attempt to further tighten the
clamshells and verify the Venous Outflow Component was connected appropriately (See: CONNECTING THE HeRO GRAFT and
ASSEMBLING THE ADAPTER sections). If a leak persists after following the previously stated troubleshooting steps, consider
one of the following two options to implant the HeRO Graft.
OPTION 1: Remove and Replace Adapter and Support Seal (if applicable)
1. Using scissors, make a straight cut to the graft close to the inflow graft end of the Adapter (Fig. 1 and 2) or the Support Seal coil (if applicable,
Fig. 3 and 4).
Fig. 1
2. Using heavy duty scissors, make a straight cut to the Venous Outflow Component near the Venous Outflow Component end of the Adapter (Fig. 5
and 6) or Adapter with Support Seal (if applicable, Fig. 7 and 8).
Fig. 5
3. Remove the Adapter, Support Seal (if applicable) and the cut portions of the graft and Venous Outflow Component (that are attached to the
Adapter). Contact Customer Service at 1-800-356-3748 for returning the removed product.
4. Deliver a new Adapter, Support Seal (if applicable) and Graft Expander to the sterile field using aseptic technique.
5. Attach the new Adapter and Support Seal (if applicable) to the implanted graft at the DPG site by following the ASSEMBLING THE ADAPTER
section.
6. Attach the Venous Outflow Component to the Adapter by following the CONNECTING THE HeRO GRAFT section.
7. Using fluoroscopy, reposition the assembled Adapter (as necessary) and verify that the radiopaque tip of the Venous Outflow Component is
positioned in the mid to upper right atrium.
8. Proceed to the GRAFT AND ARTERY CONNECTION section.
OPTION 2: Remove the Adapter, Support Seal (if applicable) and Graft and Replace with HeRO Graft Arterial Graft Component
1. Using heavy duty scissors, make a straight cut to the Venous Outflow Component near the Venous Outflow Component end of the Adapter (Fig.
9 and 10) or Adapter with Support Seal (if applicable, Fig. 11 and 12).
Fig. 9
2. Remove the Adapter, Support Seal (if applicable), graft and cut portion of the Venous Outflow Component that are attached to the Adapter.
3. Deliver a HeRO Graft Arterial Graft Component to the sterile field using aseptic technique.
4. Use according to the instructions for use included with the HeRO Graft Arterial Graft Component.
GRAFT AND ARTERY CONNECTION
1. Cut the graft to length, avoiding excessive tension or excess material. Verify there are no kinks, twists, or bends in the graft.
2. Perform the arterial anastomosis using standard surgical techniques.
Caution: Use a small diameter tapered needle with a non-cutting edge to reduce the incidence of suture hole bleeding.
3. Remove the clamp, check the device patency using standard Doppler technique. Verify there is no leakage at the Venous Outflow Component
and the graft connection sites using angiography. If there is a leak at either connection site, see TROUBLESHOOTING FOR LEAKS section.
4. Verify thrill and bruit.
5. Evaluate for steal syndrome during the implant procedure with Doppler of the radial and ulnar arteries. If steal syndrome symptoms occur, consider
surgical interventions such as:
• DRIL (distal revascularization-interval ligation) procedure
• Banding, though this may reduce the flow in the HeRO Graft
• Proximalization of the inflow
NOTE: Banding may reduce flow in the HeRO Graft.
6. Close all three incision sites.
ENGLISH
Fig. 2
Fig. 6
Fig. 10
10
Fig. 3
Fig. 7
Fig.11
Fig. 4
Fig. 8
Fig. 12