Idiomas disponibles
Idiomas disponibles
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). 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 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 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 radia-
tion (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 func-
tioning 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 the possible risk of late tissue deterioration.
3. Animal studies with bovine pericardium have reported calcification and histological
signs of deterioration as an adverse reaction. Findings include phagocytosis with
accompanying chronic inflammatory infiltrate at the interface between bovine pericar-
dium and surrounding host tissue with focal degradation of implant collagen consistent
with host vs. graft reaction.
4. 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 contain-
ing 0.2% glutaraldehyde. Sterility is assured if the package is unopened and undamaged
seal. Unused sections should be considered non-sterile and discarded.
