LeMaitre Omniflow II Instrucciones De Uso página 3

Thrombectomy
Prompt intervention when occlusion occurs has been found to restore prosthetic function. Therefore the patient should be advised
to report to the clinician if symptoms return. When performing a thrombectomy choose an embolectomy catheter of the appropriate
size and follow the catheter manufacturer's instructions for use.
To avoid damage to the wall and flow surface of the prosthesis:
1. Do NOT exert undue pressure when inflating the balloon
2. Do NOT exert undue force when withdrawing the catheter from the prosthesis.
Contraindications
The prosthesis should not be used in patients with a known hypersensitivity to ovine material or glutaraldehyde.
Potential Complications with the use of Vascular Prostheses
Complications may occur with the use or in conjunction with any vascular prosthesis and include but are not limited to: infection,
thrombosis, dilatation, aneurysm formation, pseudoaneurysm formation, suture pullout and adverse tissue responses.
Late aneurysm formation in Omniflow II has been reported (more than 4 years after implantation). Ongoing patient monitoring is
recommended.
Wall integrity of the prosthesis may be adversely affected by collagenase-producing microorganisms.
Pre-implant preparation
Prepare a sterile basin with adequate sterile physiological saline to cover the prosthesis, a sterile 20 ml syringe, sterile heparin 5,000
I.U. per ml.
Removing the prostheses from the container
STRAIGHT VASCULAR PROSTHESIS
1. Remove the seal and cap from the glass tube. Remove the silicone stopper with sterile forceps. The forceps and
stopper are discarded. Fig. 1.
2. Aseptically remove the prosthesis from the glass tube by grasping the end of the glass mandrel with sterile forceps
and lifting it gently out of the glass tube. Fig. 2. The hook on the bottom of the mandrel will prevent the graft from
slipping off the mandrel.
3. Grasp the mandrel by the hook, turn it upside down and allow the prosthesis to slide into the basin of sterile saline.
If the prosthesis does not slide off easily, gently push it down the mandrel. Do NOT pull the prosthesis.
CURVED VASCULAR PROSTHESIS
1. Aseptically remove the sterile inner bag containing the prosthesis from the outer bag. Fig. 3. Only the inner bag is
sterile.
2. Cut the corner of the inner bag with sterile scissors and allow the storage solution to drain into a container. Fig. 4.
Discard the container of storage solution.
3. Remove the prosthesis from the inner bag and place it into the basin of sterile physiological saline.
Rinsing the prosthesis
STRAIGHT VASCULAR PROSTHESIS
1. Use a sterile syringe to flush the lumen of the prosthesis with 20 ml of sterile physiological saline. Fig. 5. Repeat at
least twice.
2. Clamp one end of the prosthesis. Insert sterile heparin at a concentration of 5,000 I.U. per ml into the lumen of the
prosthesis to a maximum of 50,000 I.U (10 ml) for prostheses 35 cm and longer and to a maximum of 25,000 I.U (5
ml) for the shorter prostheses. Add sufficient sterile saline if necessary to fill the prosthesis so that the entire flow
surface of the graft is coated with the solution.
3. Apply a clamp to the other end of the prosthesis.
4. Place the prosthesis back into the basin completely covered by the sterile saline until it is time for implantation. This
should be a minimum of 10 minutes.
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