LeMaitre Flexcel 2020-01 Mode D'emploi page 2

Flexcel™ Carotid Shunt
Instructions for Use - English
Introduction
The shunt is designed to serve as an artificial passage connecting two blood vessels, allowing blood flow from
one vessel to another. This is accomplished by using a clear, flexible, conduit that is held in place by a stabilization
technique on both ends of the conduit. The shunt is sterilized by ethylene oxide gas, and is guaranteed to be sterile
unless packaging is compromised.
Product Description
The Flexcel™ Carotid Shunt is a single lumen blood conduit for use in the carotid artery. The shunt is equipped
with depth markings running the length of the device and features atraumatic tips. In addition, the shunt has a
removable tether to facilitate the removal of the shunt after the procedure.
Indication
Carotid shunts are indicated for use in carotid endarterectomy as a temporary conduit to allow for blood flow
between the common and internal carotid arteries.
Contraindications
1. The shunt is a temporary device that should not be implanted.
2. Do not use a carotid bypass shunt if the arteries demonstrate atherosclerosis that would prevent safe insertion
and placement of the shunt.
Warnings
1. Do not reuse. Do not resterilize. The shunt is for single use only.
2. Assure that the shunt is properly stabilized in the artery or slippage may occur.
3. Do not force a shunt that is too large into an artery. This may result in vessel disruption or damage.
Precautions
1. Inspect the product and package prior to use and do not use if there is any evidence that the package or the shunt
has been damaged.
2. Only qualified physicians thoroughly familiar with cardiovascular surgical procedures involving the carotid artery
should use the shunt.
3. After use, this product may be a potential biohazard. Handle and dispose of in accordance with accepted medical
practice and applicable local, state and federal laws and regulations.
Adverse Reactions
As with all vascular procedures involving the carotid arteries, complications may occur during or following carotid
endarterectomy. These complications may include, but are not limited to:
• Stroke
• Transient ischemic attack
• Neurological complication
• Embolization of blood clots, arteriosclerotic plaque or air
• Infection
• Intimal disruption
• Vessel perforation and rupture
• Hemorrhage
• Arterial thrombosis
• Arterial spasm
• Vessel occlusion
How Supplied
The shunt is supplied sterile in sealed peel-open packages. Sterility is assured as long as the packages are unopened
and undamaged.
Pre Use Test
Flush the device with saline prior to use.
Procedure
IMPORTANT: A variety of surgical techniques may be used when using the shunt. Therefore, the surgeon is best advised to
use the method that his/her own practice and training dictate to be best for the patient. Specific surgical techniques are
left to the discretion of the surgeon.
(Model 2020-01, 2020-05, 2020-11, 2020-15, 2020-21, 2020-25, 2020-31, 2020-35, 2020-41, 2020-45)
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