Merit Medical Endotek ALIMAXX-B Instrucciones De Uso página 2

ALIMaXX-B®
Uncovered Biliary Stent System
devIce deScrIptIon
The MerIt endotek™ ALIMaXX-B® Uncovered Biliary
Stent System is comprised of two components: the
radiopaque, self-expanding nitinol stent and the delivery
system. The stent comes pre-loaded on the delivery
catheter.
The stent is composed of a nitinol scaffold.
the stent is delivered, the stent expands as a result of
mechanical properties of the metal and the proprietary
stent geometry. The stent is also designed to have
minimal foreshortening, therefore, allowing increased
stent placement accuracy. To minimize the possibility of
stent migration, both ends of the stent have slightly larger
diameters. Radiopaque markers are also located on both
ends of the stent to facilitate stent placement (Figure 1).
The stent is delivered endoscopically using the 185cm
delivery catheter working length.
The stent is deployed using a dedicated delivery system.
The delivery catheter consists of an inner sheath and
an outer sheath. The outer sheath constrains the stent.
During stent deployment, the outer sheath is pulled
back to release the expanding stent. The delivery system
handle permits one-handed positioning and deployment
of the stent via a trigger mechanism (Figure 8).
once deployment is initiated, the stent cannot be
reconstrained. However, prior to the point when the
first deployment trigger is fully retracted, the stent can be
repositioned distally (towards the duodenum) by pulling
the entire delivery system toward the operator. when the
first deployment trigger has been fully retracted, this
is the last point at which the operator can reposition
the stent as just described. Several radiopaque markers
and bands (Figure 2) aid the operator in determining
stent position and deployed stent length.
The inner sheath lumen of the delivery catheter will
accommodate an 0.035" (0.89mm) guide wire.
feature is designed to allow safe guidance of the delivery
system to the intended implant site while minimizing the
risk of biliary system injury from the delivery system tip.
The complete Instructions for Use should be reviewed
before using this system.
IndIcatIonS for USe
The ALIMaXX-B® Uncovered Biliary Stent is indicated for
palliation of malignant strictures in the biliary tree.
warnInG: The safety and effectiveness of this device for
use in the vascular system have not been established and
can result in serious harm and/or death.
contraIndIcatIonS
Contraindications associated with the use of the
ALIMaXX-B® Uncovered Biliary Stent include:
• all cardIovaScUlar applIcatIonS
• Use of the device in very small intrahepatic ducts
• Stenting of a perforated duct, where leakage from the
duct could be exacerbated by the prosthesis
• Strictures that cannot be safely dilated to allow
passage of the delivery system
• Patients in whom endoscopic procedures cannot be
safely performed should not have stents placed via the
endoscopic delivery method
• Any use other than those specifically outlined under
Indications for Use
• Placement of the stent in biliary obstructions
precluding any form of cholangiography
• Use of the device in patients presenting with
coagulopathy
• Use of the device in strictures greater than 8cm in
length
coMplIcatIonS
English
Complications associated with the use of the ALIMaXX-B®
Uncovered Biliary Stent may include, but may not
be limited to, the usual complications reported for
conventional uncovered biliary stents and for endoscopic
procedures such as:
• Infection or fever
• Stent misplacement
• Stent migration
• Tumor overgrowth at the stent ends
• Sludge occlusion
• Bleeding, hemobilia
When
• Cholangitis
• Pancreatitis
• Bile duct trauma, perforation or ulceration
• Stent fracture
• Obstruction of branch ducts
• Tumor ingrowth
• Death
addItIonal caUtIonS and warnInGS
1. A stent placed over a bifurcation in the biliary system
can prevent or complicate future access by endoscopic
or other procedures.
2. Final stent placement resulting in an excessive length
of the stent protruding into the duodenum or
misplacement of the entire stent into the duodenum
may damage or obstruct the intestinal tract.
3. The ALIMaXX-B® Uncovered Biliary Stent must not
be cut prior to use and should only be implanted using
the delivery system supplied with the stent.
4. Physicians should carefully consider the decision to
implant the ALIMaXX-B® Uncovered Biliary Stent in
patients with active infections or other co-morbidities
involving the hepatobiliary system. Physicians should
also consider the standard precautions associated with
the endoscopic manipulation of a 6.5F (2.2mm)
catheter in the biliary tract.
5. Laser ablation of lesions with a stent in place could
cause patient injury.
6. Placement of a second stent within the lumen of
another stent could significantly compromise the
patency of the lumen.
This
precaUtIonS
• The device is intended for use by physicians who have
received appropriate training.
• The device should not be resterilized.
• The sterile packaging and device should be inspected
before use. If sterility or performance of the device is
suspected to be compromised, it should not be used.
• The device is intended for single use only. Do not
attempt to reload deployed stents onto the delivery
system.
• The device should be placed under fluoroscopic
monitoring.
• A complete diagnostic evaluation should be performed
prior to placement to measure the stricture length and
determine the proper stent length.
• Chemotherapy and irradiation may increase the risk
of stent migration due to tumor shrinkage, stent
erosion and/or mucosal bleeding.
• If the guide wire or delivery catheter cannot advance
through the obstructed area, do not deploy the stent.
• The stent has not been evaluated for repositioning or
removal after deployment in the biliary tract.
InStrUctIonS for USe
Materials required for Stent placement:
• ALIMaXX-B® Uncovered Biliary Stent of appropriate
length and diameter (with 185cm delivery catheter
working length)
• Duodenoscope system appropriately sized for the
endoscopic channel (6.5F [2.2mm] or larger)
• Appropriate diagnostic catheters, dilators,
sphincterotomes and accessories
• Radiopaque contrast solution
• 10ml syringe filled with sterile saline
• 0.035" (0.89mm) guide wire of at least 450cm long
(preferably stiff or extra stiff )
1. perform endoscopic retrograde
cholangiopancreatography (ercp).
1.1 Position the distal end of the endoscope in the
duodenum near the major duodenal papilla of Vater
(Figure 3).
1.2 Using fluoroscopy, locate the proximal and distal
ends of the stricture (Figure 4). Inject contrast
solution as necessary.
1.3 Insert a 0.035" (0.89mm) guide wire through the
endoscope into the biliary system, past the biliary
stricture (Figure 5).
1.4 Keep the guide wire situated through the stricture
until stent deployment is complete.
note: Dilation of the biliary stricture, with a balloon
catheter or appropriate dilator, may be performed prior
to stent implantation at the discretion of the physician.
warnInG: Do not attempt placement of the MerIt
endotek™ ALIMaXX-B® Uncovered Biliary Stent in
patients with stenoses that cannot be dilated sufficiently
to allow passage of the delivery catheter.
2. Select the appropriate Stent Size.
Using the cholangiographic maps of the patient's biliary
system as a guide, select the appropriate diameter and
length ALIMaXX-B® Uncovered Biliary Stent needed.
allow for at least 10-20mm of the stent to extend
past both margins of the stricture. If one stent does
not sufficiently cover the stricture, the second stent
should overlap at least 1cm of the initially placed stent.
(See Implanting More Than One Stent following Step 9).
the stent length should not excessively extend into
the duodenum. NOTE: The ALIMaXX-B® Uncovered
Biliary Stent does not significantly foreshorten during
deployment, therefore, stent shortening does not need to
be taken into account.
note: Mapping out the biliary tract cholangiographically
is also necessary to determine whether a branch duct may
be excluded by placement of the stent.
3. prepare the Stent System for Insertion.
3.1.Before opening the Sterile package:
Ensure that the package label is consistent with
the selected stent size and the appropriate delivery
catheter length for the specific procedure (Endoscopic
vs. Transhepatic), before opening the package.
The delivery catheter working length is 185cm.
3.2.opening the Sterile package:
Carefully inspect the pouch to ensure that the sterile
barrier has not been compromised. Use appropriate
technique for handling the device in a sterile
environment.
3.3. Before Using the Stent:
Inspect the stent (which is pre-loaded on the delivery
catheter) to ensure that the stent is completely
covered by the outer sheath of the delivery catheter.
Only the delivery catheter tip should be exposed.
Do not use the device if the stent has become
exposed. Examine the entire device for any damage
or defects before using the ALIMaXX-B® Uncovered
Biliary Stent. Do not use any defective materials.
caUtIon: Do not remove trigger safety until ready to
deploy stent.
3.4. preparing the delivery catheter:
3.4.1 To flush the guide wire lumen, attach a 10cc syringe
filled with sterile saline to the luer port on the back of
the delivery system handle (Figure 6).
3.4.2 Holding the device horizontally, flush until fluid is
visible at the tip.