LeMaitre XenoSure 0.6BV8 Mode D'emploi page 2

XenoSure® Biologic Patch
(Model Numbers 0.6BV8, 0.8BV8, 1BV6, 1BV10, 1.5BV10, 1BV14, 2BV9, 2.5BV15, 4BV4, 4BV6, 5BV10, 6BV8, 8BV14, 10BV16, 12BV25)
Processed bovine pericardial patch
Instructions for use - English
Storage
The XenoSure® Biologic Patch should be stored above 0°C (32°F). Avoid locations where extreme temperature fluctuations may occur; for example, near steam or hot
water pipes, air conditioning ducts, or in direct sunlight. REFRIGERATION IS NOT REQUIRED. FREEZING WILL SERIOUSLY DAMAGE THE XENOSURE BIOLOGIC PATCH AND
RENDER IT UNFIT FOR USE.
Device Description
The XenoSure Biologic Patch consists of one piece of bovine pericardial tissue that has been selected for minimal tissue blemishes. The tissue is treated with a
glutaraldehyde process which crosslinks the collagen fibers and minimizes antigenicity. The XenoSure Biologic Patch is liquid chemical sterilized and packaged in
a plastic jar containing sterile glutaraldehyde storage solution. The XenoSure Biologic Patch is designed to repair the body's natural organs.
The XenoSure Biologic Patches come in the following sizes:
Indications For Use
The XenoSure Biologic Patch is intended for use as a surgical patch material for cardiac and vascular reconstruction and repair, soft tissue deficiency repair,
reinforcing the suture line during general surgical procedures, and to close dura mater during neurosurgery.
The indication of "close dura mater during neurosurgery" is not approved by the French authorities in the French Republic.
Contraindications
None known.
Potential Complications
• Restenosis
• Pseudoaneurysm formation
• Infection
• Thrombosis
• Calcification
• Fibrosis
• Vessel occlusion
• Patch rupture
• Dilatation
• Myocardial infarction
• Bleeding
• Cerebrospinal fluid leakage
• Stroke
• Death
• Meningitis
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 glutaral-
dehyde 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.
Model Size (cm)
0.6BV8 0.6x8
0.8BV8 0.8x8
1BV6 1x6
1BV10 1X10
1.5BV10 1.5X10
1BV14 1x14
2BV9 2x9
2.5BV15 2.5x15
2
Model Size (cm)
4BV4 4x4
4BV6 4x6
5BV10 5x10
6BV8 6x8
8BV14 8x14
10BV16 10x16
12BV25 12x25