English
1. Description
The Niti-S Nagi™ Stent consists of an implantable metallic stent and an introducer
system.
The stent is made of Nitinol wire. It is a flexible, fine mesh tubular prosthesis which has
radiopaque markers on each end and at the center.
The Stent is loaded in the introducer system and upon deployment the body of the stent
imparts an outward radial force while both heads impart a horizontal inward force,
allowing transmural drainage.
Niti-S Nagi™ Stent is Fully Silicone Covered and can be removed; (see Warnings).
- The endoscopic introducer system has a usable length of 180cm
Endoscopic Type is recommended
- When approached endoscopically
2. Principle of Operation
The outer sheath is pulled back by immobilizing the hub in one hand, grasping the Y-
connector with the other hand, and gently sliding the Y-connector along the pusher
towards the hub. Retraction of the outer sheath releases the stent.
3. Indication for Use
The Niti-S Nagi™ Stent is intended for drainage of a pancreatic pseudocyst through a
transgastric or transduodenal approach.
WARRANTY
Taewoong Medical Co., Ltd. warrants that reasonable care has been applied within the
design and subsequent manufacturing process of this instrument. This warranty is in lieu
of and excludes all other warranties not expressly set forth herein, whether expressed or
implied by operation of law or otherwise, including, but not limited to, any implied
warranties of merchantability or fitness for a particular purpose. Handling, storage,
cleaning and sterilization of this instrument as well as other factors relating to the
patient, diagnosis, treatment, surgical procedures, and other matters beyond Taewoong's
control directly affect the instrument and the results obtained from its use. Taewoong's
obligation under this warranty is limited to the replacement of this instrument and
Taewoong shall not be liable for any incidental or consequential loss, damage, or
expense directly or indirectly arising from the use of this instrument. Taewoong neither
assumes, nor authorizes any other person to assume for it, any other or additional
liability or responsibility in connection with this instrument. Taewoong assumes no
liability with respect to instruments reused, reprocessed or resterilized and makes no
warranties, expressed or implied, including but not limited to merchantability or fitness
for a particular purpose, with respect to such instruments.
4. Contraindication
The Niti-S Nagi™ Stent is contraindicated for, but are not limited to:
- Hemodynamic instability
- Severe coagulopathy
- All others than indication for use
- Recapturing a stent during its deployment is contraindicated.
5. Warnings
The safety and efficacy of this device for use in the vascular system has not been
established.
The device should be used with caution and only after careful consideration in
patients with elevated bleeding times, coagulopathies, or in patients with radiation
colitis or proctitis.
The stent contains nickel, which may cause an allergic reaction in individuals with
nickel sensitivity.
Do not expose the introducer system to organic solvent (e.g. Alcohol)
Do not use with Ethiodol or Lipiodol contrast media.
Long-term patency of this stent has not been established and regular observation is
recommended.
The stent cannot be resheathed once deployment has been initiated.
Do not attempt to recapture/reload a stent once its deployment is advanced.
User's Manual
Model Name
Niti-S Nagi™ Stent
Figure 1. Stent Model
Figure 2. Introducer System (Endoscopic)