Indications For Use; Contraindications - GEM FLOW COUPLER Mode D'emploi

INDICATIONS FOR USE:

The FLOW COUPLER Device is a single use, implantable device that is intended to be used
in the end-to-end anastomosis of veins and arteries normally encountered in microsurgical and
vascular reconstructive procedures. The FLOW COUPLER Device includes a pair of permanently
implanted rings which secure the anastomosis and a removable Doppler probe that is press-fit
onto one of the rings. When the FLOW COUPLER Device is used in conjunction with the
FLOW COUPLER Monitor, the FLOW COUPLER System is intended to detect blood flow
and confirm vessel patency intra-operatively and post-operatively at the anastomotic site.
Post-operatively, blood flow can be detected on an as needed basis for up to 7 days. The
FLOW COUPLER Doppler probe is not intended to be a permanent implant and should be
removed 3 to 14 days post-operatively.

CONTRAINDICATIONS:

The FLOW COUPLER Device is not indicated for use in end-to-side anastomosis or for patients
presenting conditions that would normally preclude microvascular repair with suture technique.
Examples of such conditions include, but are not limited to:
• Pre-existing or suspected peripheral vascular disease,
• Ongoing irradiation of the area of reconstruction,
• Clinical infection of the area of reconstruction,
• Anticipated infection due to significant contamination of the area of reconstruction,
• Friability of the vascular tissue due to sclerotic conditions,
• Concurrent diabetes mellitus, or
• Concurrent corticosteroid therapy
The FLOW COUPLER Device and System is contraindicated for use in the central circulatory
system.
WARNINGS:
• Failure to use the Vessel Measuring Gauge to approximate the vessel size could result in using
a FLOW COUPLER Device of an inappropriate size. Using a ring too large for the vessel
may result in stressing or tearing of the vessel wall and a compromised anastomosis. Using
a ring too small for the vessel may unduly constrict the vessel and lead to thrombosis or ring
separation.
• Failure to squeeze the FLOW COUPLER jaws with a hemostat or similar instrument prior
to ejection of the joined rings may result in an inadequate friction fit and possible ring
separation. Inspect the anastomotic site to ensure that the anastomosis has been satisfactorily
completed.
• The FLOW COUPLER Device is supplied sterile and is single use only. Do not resterilize or
reuse the FLOW COUPLER Device.
- Resterilization may compromise the structural integrity of the product which may lead to
incomplete anastomosis.
- Device cannot be reused due to possible structural damage during first use which may lead to
incomplete anastomosis.
• Do not use the FLOW COUPLER Device if the package has been opened or appears to be
damaged or compromised as sterility may be compromised. Failure to observe this warning
may result in surgical infection.
• Safe use of the FLOW COUPLER Device for the anastomosis of tubular structures other than
veins and arteries has not been established.
• Safe use of the FLOW COUPLER Device for the anastomosis of growing vessels in children or
adolescents has not been established. Not intended for fetal use.
• Safe use of the probe portion of the FLOW COUPLER Device during MRI procedures has not
been established. Therefore the probe should be removed prior to a MRI procedure.
• Security of an anastomosis utilizing FLOW COUPLER Devices that have been approximated,
reopened, and then reapproximated has not been demonstrated. When reapproximation
of the anastomosis is desired, the vessel should be removed from each ring and a new
FLOW COUPLER Device utilized.
• Ensure that suture sleeve and connectors are not implanted.
• The Anastomotic Instrument, Vessel Measuring Gauge, COUPLER Forceps, and Sterilization
Tray must be sterilized prior to use.
• The Anastomotic Instrument, Vessel Measuring Gauge, COUPLER Forceps, and Sterilization
Tray should be thoroughly inspected before use. Instruments that are damaged and/or in need
of repair should not be used.
CAUTIONS:
• Use of the FLOW COUPLER Device involves potential risks normally associated with
any implanted device, e.g., infection, perforation, or laceration of vessels, erosion, implant
rejection, or device dislodgement/migration.
• The angle of the probe wire relative to the flap will be influenced by the orientation of the
Anastomotic Instrument during formation of the anastomosis. To avoid unwanted kinking or
twisting of the vessel during positioning of the flap-which may result in poor flap perfusion-
care should be taken to establish the desired angle of the probe wire relative to the flap and
to adjust the Anastomotic Instrument accordingly prior to starting the anastomosis.
• Should a probe be prematurely removed from the probe-holder, do not attempt to re-insert
the probe into the probe-holder. Instead remove rings and implant a new FLOW COUPLER
Device.
• Probe wire is delicate. The use of crushing forceps may damage the probe wire.
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