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STERILE. Sterilized with ethylene oxide gas. Nonpyrogenic. Radiopaque. For one use only. Do not autoclave.
Caution: Federal (USA) law restricts this device to sale by or on the order of a physician.
I.
Device Name
The device brand name is the Cordis PRECISE Nitinol Stent
Transhepatic Biliary System.
II.
Description
The Cordis PRECISE Nitinol Stent Transhepatic Biliary System is
designed to deliver a self-expanding stent to the biliary tree. The
system consists of stents in diameters ranging from 5 mm to
7 mm. The stents are delivered via a 5.5F (1.85 mm) system.
The self-expanding stent is composed of a nickel titanium alloy
(nitinol). The stent is a flexible, fine mesh tubular prosthesis,
which achieves its unconstrained diameter upon deployment into
biliary ducts. Upon deployment, the stent imparts an outward
radial force on the luminal surface of the duct to establish
patency.
The delivery system, as shown in Figure 1, is comprised of an
inner shaft, an outer sheath and a Tuohy Borst valve (1). The
inner shaft consists of a support member and wire lumen. The
support member is comprised proximally of a stainless steel
tube (2) and distally of a stainless steel coil (3) covered with a
polymeric jacket (14). The wire lumen (15) terminates distally in a
catheter tip (4) and originates proximally in a Luer hub (5)
designed to accept a .018" (0.46 mm) guidewire. The system has
a usable length of 135 cm.
The outer sheath has an outer diameter at the distal section (6B)
of 5.5F. The proximal section (6A) of the outer sheath is 5F
(1.65 mm). The distal section of the outer sheath houses the
crimped stent (8). The proximal section of the outer sheath
connects to the Tuohy Borst valve via a Luer hub (7). At the distal
end of the outer sheath is a radiopaque marker (11).
The self-expanding stent (8) is constrained within the space
between the wire lumen (15) and the distal section of the outer
sheath (6B). This space is flushed prior to the procedure by
injecting fluid via the Y connection (9) on the Tuohy Borst valve.
Stent movement during sheath retraction is restricted by the
proximal radiopaque marker (10) connected to the inner shaft,
which marks the trailing edge of the stent.
Stent positioning about the target stricture is achieved prior to
deployment utilizing the distal inner shaft stent marker (13) and
the proximal inner shaft stent marker (10). For stent deployment,
the Tuohy Borst valve is unlocked on the inner shaft by a counter
clockwise rotation of the proximal valve end (12). Sheath
retraction is achieved by grasping the inner shaft Luer hub (5) in
a fixed position and moving the outer sheath proximally relative
to the inner shaft. Complete deployment of the stent is achieved
when the outer sheath radiopaque marker (11) is proximal to the
inner shaft marker (10).
III.
Indications for Use
The Cordis PRECISE Nitinol Stent Transhepatic Biliary System is
indicated for palliation of malignant neoplasms in the biliary tree.
IV. Contraindications
Contraindications associated with the use of transhepatic biliary
endoprostheses include:
•
Stenting of a perforated duct where leakage from the duct
could be exacerbated by the prosthesis
•
Patients with bleeding disorders
•
Severe ascites
* Ethiodol is a trademark of Guerbet S.A.
6
V.
Warnings
•
The safety and effectiveness of this device for use in the
vascular system have not been established.
•
Persons with allergic reactions to nickel titanium (nitinol) may
suffer an allergic response to this implant.
•
The Cordis PRECISE Nitinol Stent Transhepatic Biliary
System is intended for single use only. DO NOT resterilize
and/or reuse the device.
•
The black dotted pattern on the grey temperature exposure
indicator, found on the pouch, must be clearly visible. Do not
use if entire temperature exposure indicator is completely
black as the unconstrained stent diameter may have been
compromised.
•
Do not use if the pouch is opened or damaged.
•
Use the stent system prior to the "Use By" date specified on
the package.
•
Do not use with Ethiodol* or Lipiodol contrast media.
•
Do not expose the delivery system to organic solvents (e.g.
alcohol).
•
The stent is not designed for repositioning or recapturing.
•
Stenting across a major bile duct branch could lead to
compromised future diagnostic or therapeutic procedures.
VI. Precautions
•
The device is intended for use by physicians who have
received appropriate training.
•
The delivery system is not designed for use with power
injection systems.
•
When catheters are in the body, they should be manipulated
only under fluoroscopy.
•
Radiographic equipment that provides high quality images is
needed.
•
Recrossing a partially or fully deployed stent with adjunct
devices must be performed with caution.
•
The PRECISE Nitinol Stent Transhepatic Biliary System is
shipped with the Tuohy Borst valve in the OPEN position (see
"Preparation of the Stent Delivery System") on the 5.5F stent
delivery system only.
•
Prior to stent deployment remove all slack from the catheter
delivery system (see "Stent Deployment").
•
Store in a cool, dark, dry place.
VII. Potential Complications
Potential complications associated with the use of transhepatic
biliary endoprostheses may include, but are not limited to:
•
Sepsis/infection
•
Stent misplacement
•
Stent migration
•
Stent obstruction secondary to tumor ingrowth through the
stent
•
Tumor overgrowth at the stent ends
•
Sludge occlusion
•
Pancreatitis
•
Bile duct perforation
•
Parenchymal hemorrhage
•
Liver abscess
VIII. Directions for Use
Procedure
1.
Inject Contrast Media
Perform a percutaneous cholangiogram using standard
technique.
2.
Evaluate and Mark Stricture
Fluoroscopically evaluate and mark the stricture, observing
the most distal level of the biliary stricture.
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