Potential Adverse Events; Equipment Required - Boston Scientific WallFlex Mode D'emploi

• The device is intended for single use only. Do not attempt to
reload deployed stents onto the delivery system.
• Use of fluoroscopy is recommended. Not using fluoroscopy
can result in misplacement of the stent.
Mr ConDItIonal
Non-clinical testing has demonstrated that the WallFlex™
Duodenal Stent System with Anchor Lock Delivery System is
MR Conditional. A patient with this device may undergo MRI
immediately under the following conditions:
• static magnetic field of 3 Tesla or less
• maximum spatial magnetic gradient field of 720 Gauss/cm or less
• maximum whole body averaged specific absorption rate
(SAR) of 3 W/kg for 15 minutes of scanning
In non-clinical testing, the WallFlex Duodenal Stent System with
Anchor Lock Delivery System produced a temperature rise of less
than or equal to 0.6 °C at a maximum whole body averaged specific
absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in
a 3 Tesla Excite®, G3.0-052B, General Electric Medical Systems,
Milwaukee, WI; active-shielded, horizontal field MR scanner.
MR image quality may be compromised if the area of interest is
in the same area or relatively close to the position of the WallFlex
Duodenal Stent System with Anchor Lock Delivery System.

potentIal aDverse events

Complications associated with the use of the WallFlex Duodenal
Stent System with Anchor Lock Delivery System may include:
• Hemorrhage (e.g. bleeding)
• Perforation
• Pain (e.g. discomfort, foreign body sensation)
• Migration
• Obstruction (e.g. biliary obstruction, occlusion)
• Erosion (e.g. ulceration)
• Fever
• Infection (e.g. local infection, peritonitis, septicemia)
• Death (other than that due to normal disease progression)
• Gastrointestinal reflux
• Stent misplacement or inadequate expansion

eqUIpMent reqUIreD

• Endoscope (therapeutic gastroscope or duodenoscope
with a channel size of 3.7 mm or greater)
• Fluoroscope
• 0.035 in (0.89 mm) guidewire
proCeDUre
The WallFlex Duodenal Stent System with Anchor Lock Delivery
System should be placed with the combined aid of fluoroscopy
and direct visualization with an endoscope.
1. Prepare and sedate the patient as per endoscopy protocol
for the site.
2. Pass the endoscope to the site of the stricture. Under
direct visualization and fluoroscopic guidance, pass a
0.035 in (0.89 mm) guidewire through the working channel of
the endoscope. (Radiographic contrast can also be injected
through a catheter to define the contour and dimensions of
the stricture.) Maneuver the guidewire across the site of
the stricture in preparation for stent placement.
3. Identify the stricture location, and the proximal and distal
stricture margins, using fluoroscopic and endoscopic
visualization. Fluoroscopic markers (e.g. external metal
markers taped to the skin or internal injection of radiopaque
dye) may be used to indicate the stricture margins.
Black (K) ∆E ≤5.0
4