Directions For Use; Indications For Use; Contraindications - Boston Scientific WallFlex Mode D'emploi

DIreCtIons For Use

(See Figure A for Device Diagram)
The exterior tube is pulled back by immobilizing the hub handle
in one hand, grasping the exterior tube handle with the other
hand, and gently sliding the exterior tube handle along the
stainless steel tube towards the hub handle. Retraction of the
exterior tube releases the stent.
The deployment process can be reversed if repositioning
is desired. The stent can be reconstrained by the exterior
tube if the stent Deployment Limit Marker Band has not been
passed during deployment. To reposition, first fully reconstrain
the stent by gently pushing the exterior tube handle forward
while holding the hub handle completely immobile. Once
reconstrained, the stent can be repositioned either distally or
proximally and the deployment process restarted. Reversing the
deployment process can be repeated twice, allowing a total of
three deployment attempts.

InDICatIons For Use

The device is indicated for the palliative treatment of
gastroduodenal obstructions produced by malignant neoplasms.

ContraInDICatIons

Contraindications associated with the use of the WallFlex™
Duodenal Stent System with Anchor Lock Delivery System include:
• Enteral ischemia
• Suspected or impending perforation
• Intra-abdominal abscess/perforation
• Strictures that do not allow passage of a guidewire
• Patients for whom endoscopic techniques are
contraindicated
• Any use other than those specifically outlined under
indications for use
warnInGs
• As perforation is a known risk, the stent should be used
with caution and only after careful consideration in patients
who are:
– undergoing radiation therapy and/or chemotherapy
– in advanced stages of cancer
• The device should be used with caution and only after
careful consideration in patients with elevated bleeding
times or coagulopathies.
• Stents cannot be repositioned after complete deployment.
• The safety and effectiveness of this device for use in benign
strictures have not been established.
• Chemoradiation therapy or radiotherapy alone may lead to
tumor shrinkage and subsequent stent migration.
• The stent contains nickel, which may cause an allergic
reaction in individuals with nickel sensitivity.
preCaUtIons
• Read the entire directions for use thoroughly before using
the WallFlex Duodenal Stent System with Anchor Lock
Delivery System. The WallFlex Duodenal Stent System
with Anchor Lock Delivery System should only be used
by or under the supervision of physicians thoroughly
trained in the placement of duodenal stents. A thorough
understanding of the techniques, principles, clinical
applications and risks associated with this procedure is
necessary before using the device.
• The system must not be resterilized.
• The packaging and the device should be inspected prior
to use. Do not use the device if the product is damaged
in shipping.
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Black (K) ∆E ≤5.0