Boston Scientific WallFlex Mode D'emploi page 2

WallFlex
Duodenal
Stent System with Anchor
Lock Delivery System
ONLY
Caution: Federal Law (USA) restricts this device to sale by or on
the order of a physician.
warnInG
Contents supplied STERILE using an ethylene oxide (EO) process.
Do not use if sterile barrier is damaged. If damage is found, call
your Boston Scientific representative.
For single use only. Do not reuse, reprocess or resterilize.
Reuse, reprocessing or resterilization may compromise the
structural integrity of the device and/or lead to device failure
which, in turn, may result in patient injury, illness or death.
Reuse, reprocessing or resterilization may also create a risk of
contamination of the device and/or cause patient infection or
cross-infection, including, but not limited to, the transmission of
infectious disease(s) from one patient to another. Contamination
of the device may lead to injury, illness or death of the patient.
After use, dispose of product and packaging in accordance
with hospital, administrative and/or local government policy.
DevICe DesCrIptIon
The WallFlex Duodenal Stent System with Anchor Lock Delivery
System consists of two components: the implantable metallic
stent and the Anchor Lock Delivery System (See Figure A). The
stent is composed of nitinol wire braided in a tubular mesh
configuration. This design configuration results in a stent that is
both flexible and self-expanding. The delivery system consists
in part of coaxial tubes. The exterior tube serves to constrain
the stent until retracted during deployment. The interior tube
contains a central lumen that accommodates a 0.035 in (0.89 mm)
guidewire. The device may be inserted through the working
channel of an endoscope (minimum channel diameter 3.7 mm).
There are 3 radiopaque marker bands; The Exterior Tube
Marker Band, the Deployment Limit Marker Band and the
Post Deployment Marker Band. The Exterior Tube Marker
Band is located adjacent to the leading end of the stent and
the Deployment Limit Marker Band is located adjacent to the
trailing end of the stent. The Deployment Limit Marker Band
identifies the stent deployment limit, the point beyond which the
stent cannot be reconstrained. The Post Deployment Marker
Band helps to facilitate accurate placement of the stent as it
represents the approximate final position of the trailing end of
the stent when fully expanded.
Radiopaque
Radiopaque
Exterior Tube
Post Deployment
Marker Band
Marker Band
Tip
Stent
Leading
Radiopaque
Edge of
Deployment Limit
Stent
Marker Band
Figure a
Black (K) ∆E ≤5.0
™
Exterior
Exterior
Tube Handle Stainless
Tube
Trailing Edge
Hub Handle
of Stent
2
Steel Tube
Hub