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• Secure the Stent Delivery System to the introducer
sheath; then remove the intro ducer sheath and Stent
Delivery System as a single unit.
Failure to follow these steps and / or applying excessive
force to the Stent Delivery System can potentially result in
loss or damage to the stent and / or Stent Delivery System
components.
6.4
post implant - precautions
Great care must be exercised when crossing a newly de-
ployed stent with a guide wire or balloon catheter to avoid
disrupting the stent geometry.
mRi information:
The Omnilink Elite Peripheral Stent has been shown to
be MR-Conditional immediately following implantation.
Non-clinical testing demonstrated that the Omnilink Elite
Peripheral Stent is MR-Conditional when scanned under the
following conditions:
• Static magnetic field of 3 Tesla or less
• Maximum spatial gradient magnetic field of 720 Gauss/cm
or less
MRI-related heating experiments with single and overlapping
stents at 1.5 Tesla (3 Tesla) reported whole body averaged
specific absorption rates (SAR) of 2.9 W/kg (3.0 W/kg), re-
spectively indicated the greatest amount of heating that oc-
curred in association with these specific conditions was equal
to or less than 2.6°C at 1.5 Tesla and 3.7°C at 3 Tesla. The effect
of MRI-related heating for fractured struts is unknown.
MR image quality may be compromised if the area of interest
is in the exact same area or relatively close to the position of
the Omnilink Elite Peripheral Stent. Therefore, optimization of
MR imaging parameters to compensate for the presence of
this implant may be necessary.
7.0
pOtEntial advERSE EFFECtS
Possible complications include, but are not limited to, the
following:
For Vessel Use
• Access site complications
• Additional intervention due to but not limited to:
• Stent migration
• Unintentional placement of stent
• Partial stent deployment
• Damaged stents
• Angina
• Arrhythmia
• Bleeding complications (may require transfusion)
• Bypass graft surgery
• Drug reaction to anti-platelet agents / contrast medium
• Embolization (stent or other)
• Exacerbation of pre-existing conditions
• Fever
• Hypotension / Hypertension
• Infection
• Injury to artery (rupture, perforation, dissection)
• Ischemia
• Myocardial infarction
• Nausea and vomiting
• Pseudoaneurysm
• Renal insufficiency / failure
• Restenosis of stented segment
• Seizure
• Sepsis
• Spasm
• Thrombosis / occlusion (stent or other)
For Biliary Use
• Abscess
• Additional intervention due to but not limited to:
• Stent migration
• Unintentional placement of stent
• Partial stent deployment
• Damaged stents
• Bile duct occlusion / obstruction
• Bile duct perforation potentially leading to infection
or death
• Cholangitis
• Pancreatitis
• Parenchymal hemorrhage
• Peritonitis
• Sepsis
• Tumor overgrowth at the stent ends
8.0
CliniCian USE manUal
8.1
Stent inspection prior to Use
Prior to using the Omnilink Elite Peripheral Stent System,
carefully remove the system from the package and inspect
for bends, kinks, and other damage. Verify that the stent is
located between the radiopaque balloon markers. Do not use
if any defects are noted.
8.2
materials Required
• Introducer sheath in the appropriate size and configuration
for the selected Stent Delivery System (refer to packaging
label or table 1)
• Two to three 10-20 cc syringes
• 1000 u / 500 cc Heparinized Normal Saline (HepNS)
• One 0.035" (0.89 mm) guide wire of appropriate length
• 60% contrast diluted 1:1 with normal saline
• One inflation device
• One three-way stopcock
• One torque device (if applicable)
• One guide wire introducer
8.3
lesion or Stricture preparation
1. Standard percutaneous technique should be used to place
the introducer sheath in the vessel or biliary tree. An ap-
propriate sized (0.035") guide wire should be advanced
across the lesion or stricture and into the common vessel
or bile duct.
2. Pre-dilate the lesion or stricture with an appropriate size
balloon dilatation catheter to closely match the lumen
diameter proximal and distal to the lesion or stricture.
3. Withdraw the balloon dilatation catheter leaving the guide
wire in place.
8.4
guide wire lumen Flush
1. Remove the protective cover from the tip.
2. Attach the syringe with HepNS to the guide wire port.
3. Flush until fluid exits the distal tip.
8.5
Stent delivery System preparation
1. Prepare the inflation device / syringe with diluted contrast
medium.
2. Attach the inflation device / syringe to the stopcock; attach
to the inflation port.
3. With the tip down, orient the Delivery System vertically.
4. Open the stopcock to the Delivery System; pull negative
for 30 seconds; release to neutral for contrast fill.
5. Close the stopcock to the Delivery System; purge the
inflation device / syringe of all air.
6. Repeat steps 3 through 5 until all air is expelled.
note: If air is seen in the shaft, repeat Balloon Preparation
steps 3 through 5 to prevent uneven stent expansion.
7. If a syringe was used, attach a prepared inflation device to
the stopcock.
8. Open the stopcock to the Delivery System.
9. Leave on neutral.
8.6
Stent delivery procedure
1. Wipe the exposed guide wire with heparinized saline to
remove residual blood or contrast medium.
2. Fully open the hemostatic valve. Maintain neutral pressure
on the inflation device.
3. Backload the Delivery System onto the proximal portion of
the guide wire while maintaining guide wire position across
the target lesion or stricture.
4. Advance the Delivery System over the guide wire to the
target lesion or stricture. Utilize the radiopaque balloon
markers to position the stent across the lesion or stric-
ture; perform angiography to confirm the stent position. If
applicable tighten the hemostatic valve.
note: If during the process of moving the Delivery
System into position you notice the stent has moved on
the balloon, do not deploy the stent. The entire system
should be removed as a single unit. See Stent / System
Removal - Precautions section for specific Delivery System
removal instructions.
5. The stent is now ready to be deployed.
8.7
Stent deployment procedure
CaUtiOn: Refer to the product label for expanded stent
outer diameter, nominal deployment pressure and rated
burst pressure.
1. Slowly inflate the delivery balloon to low pressure; hold until
balloon inflation is observed both proximally and distally to
the stent. Continue balloon expansion to the specified stent
deployment pressure. Confirm complete expansion of the
stent / balloon fluoroscopically. If necessary, the delivery
balloon can be used to post-dilate the stent to optimize
stent apposition.
do not exceed the Rbp. a larger pta catheter may be
used to dilate stent.
- do not expand the 4 - 5 mm stent beyond 6 mm
maximum.
- do not expand the 6 - 7 mm stent beyond 8 mm
maximum.
- do not expand the 8 - 10 mm stent beyond
11 mm maximum.
2. Deflate the balloon by pulling negative pressure on the
inflation device. Ensure that the balloon is fully deflated.
8.8
Removal procedure
1. Maintain negative pressure to allow the balloon to remain
fully deflated during removal through the sheath.
7
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