Merit Medical Hero Graft Instrucciones De Uso página 4

8. Attach the Y-adapter onto the Luer End of the 10F delivery stylet.
9. Tighten the stopcock on the Y-adapter, if necessary.
10. Ensure the valve on the stopcock is in the open position and flush with heparinized saline, then close the valve.
11. To ease insertion into the sheath, apply sterile surgical lubricant to the exterior surface of the
12. While stabilizing the guidewire and 20F sheath, begin removing the dilator from the sheath. As soon as the dilator tip has exited the sheath, immediately insert the
hemostasis plug by grasping the grip between the thumb and index finger. Firmly insert the hemostasis plug into the sheath alongside the guidewire. Ensure both
plug seal rings are fully seated within the sheath. Fully remove the dilator over the guidewire.
Venous Outflow Component
13. Insert the and delivery stylet assembly over the guidewire and advance up to the 20F peel away sheath.
Venous Outflow Component
14. Quickly exchange the hemostasis plug for the
Caution: DO NOT advance the tip of the delivery stylet into the right atrium.
Venous Outflow Component
15. Under fluoroscopic guidance, advance the
Venous Outflow Component
delivery stylet fixed, continue to advance the
NOTE
: If resistance is felt, determine the cause before continuing to advance the
from kinking. If the sheath is bent, remove it and replace it with a new short 20F sheath.
Venous Outflow Component
16. Confirm proper tip placement in the mid to upper right atrium.
17. Gently pull up while peeling away the 20F sheath. Do not peel the sheath close to the incision site; only peel the sheath as it exits the incision site. Verify that the
Venous Outflow Component
sheath has been completely removed and that the tip of the
18. Remove the guidewire and close the cap on the Y-adapter.
Venous Outflow Component
19. Prior to completing removal of the 10F delivery stylet from the
at the incision site to avoid loss of hemostasis. Complete the removal of the delivery stylet from the guidewire.
NOTE:
Be careful not to overclamp (i.e., do not advance past the locking tab on the clamp handle).
Caution: To avoid potential damage to the Venous Outflow Component, use only the atraumatic clamp provided
in the Accessory Component Kit.
20. Detach the Y-adapter from the delivery stylet. Open the stopcock and attach the Y-adapter to the silicone Luer on the
Venous Outflow Component
21. Attach a syringe to the stopcock and unclamp the
Venous Outflow Component
stopcock, reclamp the
22. Attach a syringe with heparinized saline. Open the stopcock, remove the clamp and flush the
Outflow Component
at the incision site and close the stopcock.
23. Return the patient to standard supine position.
24. Make the connector site incision at the deltopectoral groove (DPG).
Venous Outflow Component
25. Holding the away from the incision sites, use heavy duty scissors to cut the silicone Luer off of the
Outflow Component Venous Outflow Component
. The end of the
Venous Outflow Component
. Discard unused portion.
Caution: Avoid displacing the Venous Outflow Component tip during manipulation.
Caution: The cut end of the Venous Outflow Component may have sharp edges. Avoid glove contact to prevent
puncture.
26. Utilizing a standard Kelly-Wick tunneler with a 6 mm bullet tip, tunnel from the DPG to the venous incision site.
Venous Outflow Component
27. Insert the 6 mm bullet tip into the end of the
ENGLISH
Venous Outflow Component.
.
to the superior vena cava (SVC) by using a twisting motion. Holding the
to the mid to upper right atrium.
Venous Outflow Component
. Keep the sheath straight to prevent it
is in the correct location via fluoroscopy.
Venous Outflow Component
, clamp the
Venous Outflow Component
Venous Outflow Component
. Aspirate the
and remove the syringe.
Venous Outflow Component.
should be cut straight across ensuring the cut is square to the
and pull through the tunnel to the DPG.
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28. Remove the 6 mm bullet tip from the
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
Arterial Graft Component
1. Open the
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
6. Gently pull the
Component
to verify it has not twisted.
7. Leave approximately 8cm of the
Component
to the
Arterial Graft Component
8. Cut the
anastomosis site.
CONNECTING THE HeRO GRAFT
1. Place a sterile 4x4 gauze pad between the
Venous Outflow Component
2. Determine the
location. Utilizing a pair of heavy duty scissors, straight cut the
Venous Outflow Component.
the
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
Outflow Component
Venous Outflow Component
to push the
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.
. Close the
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
Venous
Reclamp the
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
Venous
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
excess material.
5. Remove the clamps at the V
Arterial Graft Component.
6. Reclamp the
NOTE:
Avoid beaded region of
7. Attach a syringe with heparinized saline to the
Observe the DPG connection site for leakage. Reclamp the
ENGLISH
Venous Outflow Component.
using aseptic technique.
Arterial Graft Component
onto the 6 mm bullet tip and secure a tight connection with a suture(s).
through the tunnel to the arterial incision site. Utilize the markings on the
Arterial Graft Component
exposed at the DPG incision site to facilitate the connection from the
Venous Outflow Component.
from the tunneler and use a standard vascular clamp to occlude the
Venous Outflow Component
and the DPG incision site to prevent debris from contaminating the incision.
length required to make the connection to the
Venous Outflow Component
Venous Outflow Component
onto the titanium connector. Connecting the two components is done by grasping the
approximately 2cm back from the cut edge and pushing so it slides more easily over the first barb of the titanium connector. Continue
onto the connector until the cut edge is flush with the silicone sleeve hub past both barbs.
Arterial Graft Component
enous Outflow Component
and arterial anastomosis sites to backbleed the entire HeRO Graft.
Arterial Graft Component
.
Arterial Graft Component
using a syringe adapter. Remove the clamp and flush the entire HeRO Graft.
Arterial Graft Component.
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Arterial Graft
Arterial Graft
Arterial Graft Component
at the
Arterial Graft Component
at the final DPG
to the desired length ensuring that the cut is square to
Venous
from the arterial end to remove