Synovis Peri-Guard Mode D'emploi page 5

by contact with chemicals or substances (other than saline), by freezing, or
by exposure to steam, gas (ethylene oxide), or radiation sterilization has not
been investigated (see Warnings).
Use of product following compromise in sterility may result in infection
(see Warnings).
When used as a bioprosthetic heart valve, bovine pericardium has been
reported to show mechanical disruption of leaflets and mineralization
resulting in early failures in some cases.
When bovine pericardium is used for pericardial closure, cases of epicardial
inflammatory reactions and adhesions of the bovine pericardium to the
heart have been reported. Pericardial adhesions may increase the difficulty
of repeat sternotomy.
When used to correct simple complete transposition of the great arteries
with pericardium augmentation of the pulmonary venous channel, bovine
pericardium has been reported to demonstrate calcification, inflammation,
and formation of fibrous tissue which obstructed pulmonary venous flow.
When used in animal studies for pericardial closure, bovine pericardium
has been reported to show signs of calcification. Animal studies have
reported histological signs of deterioration of implanted bovine
pericardium. Findings include active phagocytosis with accompanying
chronic inflammatory infiltrate and the formation of giant cell infiltrate at
the interface between bovine pericardium and surrounding host tissues
(with focal degradation of implant collagen) consistent with a host-versus-
graft reaction.
The incidence rates of host reactions (calcification, infection, rejection,
adhesion, and hematological compatibility) during use for hernia repair
have not been investigated.
DISCLAIMER OF WARRANTIES:
Synovis Surgical Innovations (SSI), a division of Synovis Life Technologies,
Inc., warrants that reasonable care has been used in the manufacture of this
device. This warranty is exclusive and in lieu of all other warranties
whether expressed, implied, written or oral, including, but not limited to,
any implied warranties of merchantability or fitness. As a result of
biological differences in individuals, no product is 100% effective under all
circumstances. Because of this fact and since SSI has no control over the
conditions under which the device is used, diagnosis of the patient, methods
of administration or its handling after it leaves its possession, SSI does not
warrant either a good effect or against an ill effect following its use. The
manufacturer shall not be liable for any incidental or consequential loss,
damage or expense arising directly or indirectly from the use of this device.
SSI will replace any device which is defective at the time of shipment. No
representative of SSI may change any of the foregoing or assume any
additional liability or responsibility in connection with this device.
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