Merit Medical HERO GRAFT Mode D'emploi page 11

POST IMPLANT INFORMATION
1. Complete the Implant Notification Fax Form in the Patient Information Pouch and fax the completed form to the patient's dialysis center.
2. The healthcare provider must supply the patient with the remaining items in the Patient Information Pouch.
3. The healthcare provider is responsible for instructing the patient on proper postoperative care.
TROUBLESHOOTING FOR LEAKS
1. 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).
2. 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 the Adapter, Anastomose an Interpositional Graft, and Attach a New Adapter
1. Using scissors, make a straight cut to the graft close to the inflow graft end of the Adapter (Fig. 13 and 14) or the Support Seal coil (if applicable,
Fig. 15 and 16).
Fig. 13
2. Using heavy duty scissors, make a straight cut to the Venous Outflow Component near the Venous Outflow Component end of the Adapter (Fig.
17 and 18) or Adapter with Support Seal (if applicable, Fig. 19 and 20).
Fig. 17
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. Measure the length that is required for the interpositional graft. The measured length should exceed the lengths of the cut portions of the graft,
Support Seal (if applicable), and Venous Outflow Component that were removed during steps 1 and 2.
5. Deliver a new graft (from Table 1 or 2, ASSEMBLING THE ADAPTER) to the sterile field using aseptic technique.
6. Measure the precise length that is required for the interpositional graft and transversely cut the graft to length.
7. Using the new graft segment, sew an end-to-end anastomosis to the implanted graft at the DPG site.
8. Deliver a new Adapter, Support Seal (if applicable), and Graft Expander to the sterile field using aseptic technique.
9. Attach a new Adapter and Support Seal (if applicable) to the graft by following the ASSEMBLING THE ADAPTER section.
10. Attach the Venous Outflow Component to the Adapter by following the CONNECTING THE HeRO GRAFT section.
11. 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.
12. Proceed to Step 3 of the GRAFT AND ARTERY CONNECTION section.
OPTION 2: Remove the Adapter 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.
21 and 22) or Adapter with Support Seal (if applicable, Fig. 23 and 24).
Fig. 21
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. Follow the instructions for use included with the HeRO Graft Arterial Graft Component.
VASCULAR ACCESS CANNULATION
Follow KDOQI guidelines for graft assessment, preparation and cannulation.
NOTE: Consult the graft manufacturer's IFU for more information regarding the cannulation of the commercially available graft selected for use with
the Adapter and Support Seal (if applicable).
• Swelling must subside enough to allow palpation of the entire graft.
• Rotation of cannulation sites is needed to avoid pseudoaneurysm formation.
• A light tourniquet may be used for cannulation as the thrill and bruit may be softer than a conventional ePTFE graft due to the elimination of the
venous anastomosis.
Post-dialysis, and following needle removal, apply moderate digital pressure at the puncture site until hemostasis is achieved. To decrease the risk
of an occlusion, do not use mechanical clamps or straps.
Caution: DO NOT cannulate the HeRO Graft within 8cm (3") of the DPG incision to avoid damage to the Support Seal (if applicable).
Caution: DO NOT cannulate the Venous Outflow Component.
Caution: Remove the bridging catheter as soon as possible once the HeRO Graft is ready to be cannulated to decrease the risk of an
infection related to the bridging catheter.
Caution: All bridging catheters should be cultured upon explant. In the event catheter tip cultures are positive, treat the patient
with appropriate antibiotics to decrease the risk of the HeRO Graft becoming infected.
For additional information refer to the HeRO Graft Care & Cannulation Guide or review it online at www.merit.com/hero.
PERCUTANEOUS THROMBECTOMY
The HeRO Graft will require maintenance equivalent to conventional ePTFE grafts. The HeRO Graft can be up to 130cm long; thus requiring a longer
thrombectomy device to traverse the entire length of the device.
Caution: Do not use mechanical/rotational thrombectomy devices (e.g., Arrow-Trerotola PTD
Adapter as internal damage may occur to these components.
For specific thrombectomy instructions or guidance, please contact Customer Service at 1-800-356-3748 for a copy of the Thrombectomy Guidelines
or it may also be found on www.merit.com/hero.
ENGLISH
Fig. 14
Fig. 18
Fig. 22
Fig. 15
Fig.19
Fig.23
11
Fig. 16
Fig. 20
Fig. 24
) in the Venous Outflow Component and
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