Balloon Expandable Biliary Stent Instructions for Use - eV3

Balloon Expandable Biliary Stent
Instructions for Use:
DESCRIPTION
The IntraStent ® LD Biliary Stent is a balloon
expandable stent. It is intended as a permanently
implanted device. The stent is made from a 316L
stainless steel tube cut into an open lattice design. It is
designed to be crimped onto a non-compliant PTA
balloon catheter that is indicated for biliary stent
expansion. After mounting onto a balloon catheter, it is
deployed and expanded by inflating the balloon.
INTENTED USE
The stent is intended as a palliative treatment of
malignant neoplasms in the biliary tree.
CONTRAINDICATIONS
None known.
GENERAL WARNINGS/PRECAUTIONS
• The safety and effectiveness of this device for use
in the vascular system have not been established.
• The stent is provided STERILE for one use only
and should be used by the “Use Before Date”
printed on the package.
• Carefully inspect the sterile package and stent
prior to use to verify that neither has been
damaged during shipment.
• The inflation diameter of the balloon used during
stent delivery should approximate the diameter of
the obstructed duct and intended implant site.
• The balloon inflation pressure should not exceed
the maximum inflation pressure recommended by
the manufacturer. An inflation device with a
manometer is recommended.
• Do not retract the balloon (catheter) unless the
balloon is fully deflated under vacuum.
• If resistance is encountered at any time during the
insertion procedure, do not force passage.
• If resistance occurs during movement through the
sheath, the stent/delivery assembly should be
withdrawn carefully.
• If resistance occurs after the stent has exited the
sheath or if the stent cannot be delivered to the
appropriate target lesion, attempting to retract the
stent/delivery assembly into the sheath may result
in stent embolization. The sheath and
stent/delivery assembly should be withdrawn as
described below.
1. Under fluoroscopic guidance, retract the
stent to the exit of the sheath.
2. Inflate the delivery balloon to one
atmosphere to help reduce the
likelihood of stent slippage or
embolization.
3. While preserving the guidewire position,
retract the sheath and stent/delivery
assembly.
4. Withdraw the sheath and stent/delivery
assembly together.
• Recrossing of newly implanted stents (with other
devices) should be done very carefully; it may
cause damage to the stent architecture.
• The stent may cause artifacts with MRI scans due
to distortion of the magnetic field. The artifacts
caused by the 316L stainless steel stent should
not be greater than those caused by metal surgical
clips. An MRI scan should not be performed until
the implanted stent has had a chance to heal
(estimated to be 8 weeks), in order to minimize the
risk of migration of the stent under a strong
magnetic field.
POTENTIAL HAZARDS AND SIDE
EFFECTS
• Infection secondary to contamination of the stent
may lead to cholangitis, hemobilia, peritonitis, or
abscess.
• The stent may migrate from the site of implant
down the biliary tract.
• Overstretching of the duct may result in rupture.
• Because the stent is made of 316L stainless steel,
persons with known allergic reactions to 316L
stainless steel may suffer an allergic response to
this implant.
PROCEDURE
NOTE: The administration of prophylactic
antibiotics may minimize the incidence of
cholangitis. Procedures are tolerated well with IV
analgesia.
Typically this is a two-step procedure. First, the
stricture is negotiated with a guidewire and an
internal/external biliary drain is positioned through the
stricture. Second, the transhepatic tract is accessed
through the routine transhepatic approach (a lateral
incision is placed between the 10 th and 11 th intercostal
space, then punctured upwards under fluoroscopy
aiming at the 9 th or 10 th vertebral body).
• No predilation is done with malignant strictures,
but a large lumen catheter may be inserted.
Subsequent dilation is generally for a few seconds
only.
Resistance may cause damage. • Refer to pouch or outer box label for appropriate
sized sheath.
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STENT AND PTA BALLOON CATHETER
ASSEMBLY PREPARATION
1. Select a stent and non-compliant PTA
balloon dilation catheter for the duct into
which the stent will be implanted. The
nominal diameter of the balloon should
approximate the diameter of the obstructed
duct and intended implant site.
NOTE: Use a balloon that requires a 7 Fr or a
larger sheath. A smaller balloon may not have
a large enough diameter to allow optimal
crimping of the stent to the balloon.
2. Remove the stent from the package and rinse
in sterile saline.
3. Remove the balloon catheter from the sterile
package in preparation for stent mounting.
4. Preinflate the balloon to ensure the balloon
opens uniformly.
5. Refold the balloon per manufacturer’s
instructions.
6. Visually inspect the balloon to assure that it is
properly folded to its lowest profile before
stent application.
7. If balloon has a lubricious coating, use a
saline saturated sterile gauze to gently wipe
the folded balloon to reduce the lubricious
coating.
8. Carefully insert the distal tip of the
unexpanded balloon, while maintaining
balloon fold into the angled end of the stent
mounting tube (Figure 1.)
9. While holding the cap of the mounting tube,
gently pinch the mounting tube behind the
stent and slide the stent onto the balloon.
(Figure 2). Do not compress the stent on the
mounting tube. This may potentially crimp
the stent to the mounting tube (Figure 2a).
10. Continue to slide the stent over the balloon
while using the balloon radiopaque markers
for centering the balloon (Figure 3).
11. Gently using the thumbs and index fingers of
both hands, crimp the stent onto the balloon
from all directions to ensure full adherence of
the stent to the balloon.
12. Flush the balloon catheter lumen with saline,
then load the stent/delivery assembly onto
the guidewire.
13. Apply a pressure of one atmosphere to the
balloon to slightly preinflate both balloon
cones.
14. Verify both balloon cones are slightly inflated.
15. Maintain this low pressure during insertion of
the stent/delivery assembly.
STENT/DELIVERY ASSEMBLY
INSERTION
1. The stent/delivery assembly is advanced
through the appropriate sized sheath, over
the guidewire into correct position. If a
hemostatic valve is present on the introducer
sheath, a metal introducer tube can be used
to facilitate advancement of the stent.
2. Position the stent across the target stricture.
The distal portion of the stent should be
positioned so that it completely covers the
distal extent of the stricture.
NOTE: Care should be taken to fully cover
the area proximal and distal to an inoperable
malignant tumor with the stent to protect
against impingement from further tumor
growth.
3. Pull back on the sheath to fully expose the
stent. Expand the stent by inflating the
balloon catheter to the nominal inflation
pressure. Appropriate expansion of the
balloon/stent should be determined using
fluoroscopy. Do not exceed the balloon
catheter manufacturer’s recommended
maximum balloon inflation pressure.
4. The diameter of the stent can be sized to the
lumen of the bile duct.
5. Deflate the balloon.
6. Rotate the deflated balloon delivery catheter
to ensure the stent is free and properly
deployed.
7. Remove the delivery catheter.
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PRODUCT
STENT SIZE
EXPANDED STENT RECOMMENDED
CODE
UNMOUNTED
DIMENSIONS
BALLOON CATHETER
DIAMETER LENGTH DIAMETER LENGTH DIAMETER/LENGTH
(mm) (mm) (mm) (mm)
(mm)/(cm)
S17-16 3.8 16.0 9.0 16.0 9.0/2.0
10.0
10.0/2.0
12.0
12.0/2.0
S17-26 3.8 26.0 9.0 26.0 9.0/3.0
10.0
10.0/3.0
12.0
12.0/3.0
S17-36 3.8 36.0 9.0 36.0 9.0/4.0
10.0
10.0/4.0
12.0
12.0/4.0
S18-16 4.5 16.0 12.0 16.0 12.0/2.0
S18-26 4.5 26.0 12.0 26.0 12.0/3.0
S18-36 4.5 36.0 12.0 36.0 12.0/4.0
CAUTION: Federal (U.S.A.) law restricts this device to sale by or on the order of a physician.
WARRANTY DISCLAIMER
Although this product has been manufactured under carefully controlled conditions, ev3 Inc. has no control over the
conditions under which this product is used. ev3 Inc. therefore disclaims all warranties, both express and implied, with
respect to the product including, but not limited to, any implied warranty of merchantability or fitness for a particular
purpose. ev3 Inc. shall not be liable to any person or entity for any medical expenses or any direct, incidental or
consequential damages caused by any use, defect, failure or malfunction of the product, whether a claim for such
damages is based upon warranty, contract, tort or otherwise. No person has any authority to bind ev3 Inc. to any
representation or warranty with respect to the product.
The exclusions and limitations set out above are not intended to, and should not be construed so as to contravene
mandatory provisions of applicable law. If any part or term of this Disclaimer of Warranty is held to be illegal,
unenforceable or in conflict with applicable law by a court of competent jurisdiction, the validity of the remaining
portions of this Disclaimer of Warranty shall not be affected, and all rights and obligations shall be construed and
enforced as if this Disclaimer of Warranty did not contain the particular part or term held to be invalid.
4600 Nathan Lane North
Plymouth, MN 55442-2920 USA
PH: 763.398.7000
800.716.6700
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©2005 ev3 Inc. All rights reserved.
Printed in the U.S.A.
T H E E N D O V A S C U L A R C O M P A N Y
IntraStent, Mega and Max are trademarks of ev3
Inc.
Protected under one or more of the following: US
Patent 6,827,732; 6,558,415; 6,358,274;
6,254,631; 6,132,460. Non-US patents pending.
Page 3 45-2344-000, C FEB/05