LeMaitre XenoSure Mode D'emploi page 3

• Cerebrospinal fluid leakage
• Stroke
• Death
Warnings
The principal complications that have been reported for bovine pericardial
tissue are fibrosis and infection. These complications are observed only in
a small minority of patients after implantation of the bovine pericardial
tissue.
Precautions
All persons responsible for the handling and preparation of the XenoSure
Biologic Patch must exercise utmost care to avoid damage to the XenoSure
Biologic Patch tissue.
• 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) or above
40°C (104°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 flush 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 expose the XenoSure Biologic Patch to antibiotics and or
antimycotics as their substances may alter the cross linking of the
aldehyde cured tissue.
• 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-fixed bovine pericardium may be subject to late attack
by the immune system with subsequent tissue deterioration. The
benefits of use of the XenoSure Biologic Patch must be weighed against