LeMaitre XenoSure 0.6BV8 Mode D'emploi page 3

• DO NOT implant the 12x25cm XenoSure Patch in patients under 25kg (See Adverse Effects).
• DO NOT handle the XenoSure Biologic Patch with traumatic instruments. This may damage the device.
• DO NOT use any XenoSure Biologic Patch that has been damaged. Device integrity may be compromised.
• DO NOT attempt to repair the XenoSure Biologic Patch. Should damage to the XenoSure Biologic Patch occur before implantation, replace the XenoSure
Biologic Patch.
• DO NOT resterilize. Unused sections should be considered non-sterile and discarded.
• DO NOT expose the XenoSure Biologic Patch to steam, ethylene oxide, chemical or radiation (gamma/electron beam) sterilization. Damage may result!
• DO NOT use cutting suture needles or cutting point armed sutures. This may damage the device.
• DO NOT allow the patch tissue to dry out during handling.
• DO NOT use if the device is beyond the expiration date.
Adverse Effects
The XenoSure Biologic Patch is designed to repair the body's natural organs. Improper functioning of an implanted XenoSure Biologic Patch produces symptoms
identical to symptoms that arise from deficiencies in the natural organ. It is the responsibility of the implanting surgeon to inform the patient of the symptoms
that indicate improper functioning of the XenoSure Biologic Patch.
1. Complete heart block and right bundle branch block are known complications reported for procedures involving cardiac repair near the A-V conduction
bundles.
2. Glutaraldehyde-treated tissue may be subject to late attack by the immune system with subsequent tissue deterioration. The benefits of use of the Xeno-
Sure Biologic Patch must be weighed against the possible risk of late tissue deterioration.
3. Residual glutaraldehyde presents a risk of toxicological effects. Completing the appropriate rinsing procedure as listed within the IFU is necessary to reduce the
risk of acute toxicological effects. Review of published literature has not resulted in an established safe limit for glutaraldehyde exposure when implanted within
the vasculature. The risks increase when implanting large amounts of glutaraldehyde treated tissue (e.g. Multiple large patches) or within patients with less
mass. The benefits of use of the XenoSure Biologic Patch must be weighed against the possible risk of toxicological effects.
4. Animal studies with bovine pericardium have reported calcification and histological signs of deterioration as an adverse reaction. Findings include phagocy-
tosis with accompanying chronic inflammatory infiltrate at the interface between bovine pericardium and surrounding host tissue with focal degradation of
implant collagen consistent with host vs. graft reaction.
5. Bovine pericardium used for pericardial closure has been associated with epicardial inflammatory reactions and adhesions of the patch to the heart. Pericardial
adhesions may increase the difficulty of repeat sternotomy.
How Supplied
One XenoSure Biologic Patch is provided sterile and non-pyrogenic in a sealed container; DO NOT RESTERILIZE. The patch is stored in a sterile phosphate
buffered saline solution containing 0.2% glutaraldehyde. Sterility is assured if the package is unopened and has an undamaged seal. Unused sections should be
considered non-sterile and discarded.
Directions For Use
Choose the required XenoSure Biologic Patch model as appropriate for the type of procedure being performed. The XenoSure Biologic Patch can be cut to a size
appropriate for a given repair. XenoSure Biologic Patch is for SINGLE USE ONLY.
Patch Preparation
Surgical gloves must be thoroughly washed to remove all powder residues before handling the XenoSure Biologic Patch.
Examine the information of the jar label to verify selection of the correct XenoSure Biologic Patch size. Carefully inspect the entire container and tamper-evident
seal for damage.
DO NOT USE THE XENOSURE BIOLOGIC PATCH IF THE JAR IS DAMAGED OR IF THE SEAL IS BROKEN. Do not discard the product. Please contact your distributor for
further instructions.
Rinse Procedure
The appropriate rinse procedure, per attached table, must be followed in order to reduce patients exposure to residual glutaraldehyde. Rinse multiple patches
separately with new sterile saline.
Remove the tamper-evident outer plastic seal and unscrew the jar cap. The contents of the jar are sterile and must be handled aseptically to prevent contamina-
tion. The outside of the jar is not sterile and must not enter the sterile field.
From the jar, remove the XenoSure Biologic Patch by grasping its corners with sterile, atraumatic forceps.
Once removed from the container, submerge the XenoSure Biologic Patch in the sterile saline. Using the same forceps, gently agitate the XenoSure Biologic Patch
in the basin. Allow the XenoSure Biologic Patch to remain in the rinse basin until required by the surgeon.
At the surgeon' s discretion the rinse solution may contain bacitracin (500 U/mL) or cephalexin (10 mg/mL), as testing has shown that the XenoSure® bovine
pericardial patch material is not adversely affected by treatment with those antibiotics. The effects of other antibiotics or the long term effects of these antibiotics on
the XenoSure® bovine pericardial patch material have not been tested. Use antibiotics only as indicated by the antibiotics manufacturer.
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