LeMaitre XenoSure Mode D'emploi page 3

• FOR SINGLE USE ONLY. Do not reuse, reprocess, or resterilize. Reuse,
reprocessing, and/or resterilization of the device and/or failure could
cause patient injury, illness or death. Any unused pieces of XenoSure
Biologic Patch must be discarded. Note product "Use By" date.
• INSPECT sealed sterile package before opening. If seal is broken,
contents may not be sterile and may cause infection in the patient. DO
NOT USE. Do not discard the product. Please contact your distributor for
further instructions.
• DO NOT expose the device to temperatures below 0°C (32°F). FREEZING
WILL SERIOUSLY DAMAGE THE XENOSURE BIOLOGIC PATCH AND RENDER
IT UNFIT FOR USE. DO NOT STORE UNDER REFRIGERATION.
• RINSE the device according to the "RINSE PROCEDURE" section of this
booklet before using. The XenoSure Biologic Patch storage solution
contains glutaraldehyde and may cause irritation of skin, eyes, nose and
throat. DO NOT BREATHE STORAGE SOLUTION VAPOR. Avoid prolonged
skin contact and immediately fl ush area with water. In case of contact
with eyes, seek medical assistance immediately. The liquid chemical
storage solution should be disposed according to hospital procedure.
• DO NOT handle the XenoSure Biologic Patch with traumatic instru-
ments. 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 Eff ects
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 defi ciencies 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 im-
mune system with subsequent tissue deterioration. The benefi ts of use
of the XenoSure Biologic Patch must be weighed against the possible
risk of late tissue deterioration.
3. Residual glutaraldehyde presents a risk of toxicological eff ects. Complet-
ing the appropriate rinsing procedure as listed within the IFU reduces the
residual glutaraldehyde on the patch to an acceptable level and therefore
signifi cantly reduces the risk of acute toxicological eff ects. 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
benefi ts of use of the XenoSure Biologic Patch must be weighed against
the possible risk of toxicological eff ects.
4. Animal studies with bovine pericardium have reported calcifi cation
and histological signs of deterioration as an adverse reaction. Findings
include phagocytosis with accompanying chronic infl ammatory
infi ltrate 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 infl ammatory reactions and adhesions of the patch to
the heart. Pericardial adhesions may increase the diffi culty 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 phos-
phate buff ered saline solution containing 0.2% glutaraldehyde. Sterility is
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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
contamination. The outside of the jar is not sterile and must not enter the
sterile fi eld.
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 aff ected by treatment with
those antibiotics. The eff ects of other antibiotics or the long term eff ects of
these antibiotics on the XenoSure® bovine pericardial patch material have not
been tested. Use antibiotics only as indicated by the antibiotics manufacturer.
Model Size (cm)
0.6P8 0.6x8
0.8P8 0.8x8
1P6 1x6
1P10 1x10
500ml for 2 minutes
1.5P10 1.5x10
1P14 1x14
2P9 2x9
4P4 4x4
4P6 4x6
6P8 6x8
1000ml for 3 minutes
8P14 8x14
10P16 10x16
Alternate Patch Size Rinse Procedure
For any patch size not listed in the table, use the following rinse instruc-
tions.
Patch length (cm) x Patch width (cm) = Patch area (cm
If the patch has an area less than or equal to 37.5 cm
rinse time of 2 minutes in 500ml of saline.
2
If the patch has an area greater than 37.5 cm
2
300cm , the patch requires a rinse time of 3 minutes in 1000ml of saline.
Note: The patch area is based on one side of the patch. This calculation has
been formulated intentionally. Please follow the instructions.
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Rinse Procedure
minimum
minimum
2 )
2 , the patch requires a
and less than or equal to