English - Abbott Omnilink Elite Instrucciones De Uso

Omnilink ElitE
peripheral Stent System
1.0 dEviCE dESCRiptiOn
The device brand name is Omnilink Elite Peripheral Stent
System. For stent and balloon dimensions, see packaging
labels or table 1.
• A flexible, balloon-expandable L605 cobalt-chromium
stent pre-mounted on the balloon of an over the wire stent
delivery system. Delivery system is compatible with 0.035"
(0.89 mm) guide wires and comes in lengths of 80 cm and
135 cm.
• Two radiopaque markers located underneath the balloon,
which identify the stent position and fluoroscopically mark
the working length of the balloon.
The delivery system can be utilized to optimize the stent wall
apposition post stent deployment.
See page 4 table 1 - in vitro device Specifications .
2.0 hOw SUppliEd
Contents. One each: Omnilink Elite Peripheral Stent
System.
Storage. Keep dry, keep away from sunlight, temperature
limitation 15°C - 30°C (59°F- 86°F).
non pyrogenic.
Sterile. Sterilized with electron beam radiation. Do not use if
package is open or damaged.
This single use device cannot be reused on another patient,
as it is not designed to perform as intended after the first
usage. Changes in mechanical, physical, and/or chemical
characteristics introduced under conditions of repeated use,
cleaning, and/or resterilization may compromise the integrity
of the design and/or materials, leading to contamination due
to narrow gaps and/or spaces and diminished safety and/or
performance of the device. Absence of original labeling may
lead to misuse and eliminate traceability. Absence of original
packaging may lead to device damage, loss of sterility, and
risk of injury to the patient and/or user.
3.0 indiCatiOnS
The Omnilink Elite Peripheral Stent System is indicated for the
treatment of de novo or restenotic atherosclerotic lesions in
protected peripheral arteries and palliation of malignant stric-
tures in the biliary tree.
4.0 COntRaindiCatiOnS
The Omnilink Elite Peripheral Stent System is contraindicated
for use in:
Vessel Use:
• Patients with a contraindication for anti-platelet / anti-
coagulant therapy
• Aneurysms immediately adjacent to the stent implantation
site
• Presence of fresh, unlysed, unorganized thrombus or
embolic material
• Target lesions that are resistant to complete balloon
inflation
• Patients with a known hypersensitivity to cobalt or chrome
6

English

• Patients with a known hypersensitivity to silicone
Biliary use:
• Patients with bleeding disorders
• Use in perforated duct where the leakage can be enhanced
by the prosthesis
• Severe ascites
• Patients with a known hypersensitivity to cobalt or chrome
• Patients with a known hypersensitivity to silicone
5.0 waRningS
• Do not use if package is open or damaged.
Should unusual resistance be felt at any time during
lesion access or Stent Delivery System removal, the introducer
sheath and Stent Delivery System should be removed as
a single unit. If possible, retain the guide wire position for
subsequent vessel access. Applying excessive force to the
Stent Delivery System can potentially result in loss or damage
to the stent and Stent Delivery System components. (See
Stent / System Removal – Precautions)
• Since the use of this device carries the associated risk
of subacute thrombosis, vascular complications and /
or bleeding events, judicious selection of patients is
necessary.
• Once fully deployed, the stent cannot be repositioned
• This device should be used only by physicians trained in
angiography and percutaneous transluminal angioplasty
and/or biliary stent placement and cholangiography.
• The Omnilink Elite Peripheral Stent System is intended to
perform as a system. The stent should not be removed
for use in conjunction with other dilatation catheters, nor
should the Omnilink Elite Peripheral Stent System be used
in conjunction with other stents.
• When multiple stents are required, stent materials should
be of similar composition.
6.0 pRECaUtiOnS
Subsequent restenosis may require repeat dilatation of the
vessel segment containing the stent. The long-term outcome
following repeat dilatation of endothelialized Omnilink Elite
Peripheral Stents is unknown at present.
Estimated vessel / duct reference size should not be less than
4.0 mm in diameter or bigger than 11.0 mm in diameter.
6.1 Stent delivery System handling -
precautions
• This device is designed for single use only. Do not resterilize
or reuse.
• Use the Stent System prior to the "Use By" date specified
on the package.
• do not remove the stent from its delivery balloon
as removal may damage the stent and / or lead to stent
embolization.
• Carefully inspect the Omnilink Elite Peripheral Stent System
prior to use to verify that the stent has not been damaged
in shipment and that the device dimensions are suitable
for the specific procedure. Take care to avoid unneces-
sary handling.
• Do not "roll" the mounted stent with your fingers as this
action may loosen the stent from the delivery balloon.
• Use only the appropriate balloon inflation media. Do not
use air or any gaseous medium to inflate the balloon as this
may cause uneven expansion and difficulty in deployment
of the stent.
• Refer to the instructions for use supplied with any interven-
tional devices to be used in conjunction with Omnilink Elite
Peripheral Stent System, for their intended uses, contrain-
dications, and potential complications.
• Never advance delivery balloon catheter without the guide
wire extending from the tip.
6.2 Stent placement - precautions
• Do not prepare or pre-inflate the balloon prior to stent
deployment other than as directed. Use the balloon-
purging technique described in the Clinician Use Manual
in section 8.0.
• The expanded stent outer diameter should approximate
the diameter of the vessel/duct. Oversizing of the stent can
result in a ruptured vessel / duct. To ensure full expansion
of the stent, the balloon should be inflated to a minimum
of nominal pressure.
• Implanting a stent may lead to dissection or perforation of
the vessel / duct distal and / or proximal to the stent and
may cause acute closure of the vessel / duct requiring addi-
tional intervention (surgical intervention, further dilatation,
placement of additional stents, or other).
• When treating multiple lesions, the distal lesion should be
initially stented, followed by stenting of the proximal lesion.
Stenting in this order obviates the need to cross the proxi-
mal stent in placement of the distal stent and reduces the
chances for dislodging the stent.
• Do not expand the stent if it is not properly positioned in the
vessel / duct. (See Stent / System Removal – Precautions)
• Fretting corrosion on overlapped Omnilink Elite Stents in
bile ducts has not been tested.
• Stenting across a major bifurcation may hinder or prevent
future side branch access.
• Balloon pressures should be monitored during inflation.
do not exceed the Rated burst pressure (Rbp) as in-
dicated on product label. Use of pressures higher than
specified on the product label may result in a ruptured bal-
loon with possible vessel / duct damage or perforation.
• do not attempt to pull an unexpanded stent back
through the introducer sheath; dislodgement of the
stent from the balloon may occur.
• Stent retrieval methods (use of additional wires, snares
and / or forceps) may result in additional trauma to the
duct / vasculature and / or the duct / vascular access
site. Complications may include bleeding, hematoma or
pseudoaneurysm.
• The Omnilink Elite Peripheral Stent System is intended for
deployment and post-deployment dilatation of the stent
only and should not be used to dilate other locations.
6.3 Stent / System Removal -
precautions
Should unusual resistance be felt at any time during either
vessel / duct access or during removal of an undeployed stent,
the Stent Delivery System and introducer sheath should be
removed as a single unit. If possible, retain the guide wire
position for subsequent vessel / duct access.
when removing the Stent delivery System as a single unit:
• DO NOT retract the Stent Delivery System into the
introducer sheath.
• Position the proximal balloon marker just distal to the tip of
the introducer sheath.
• Advance the guide wire in the anatomy as far distally as
safely possible.