Taewoong Niti-S, User Manual, Page: 5 / 56

Post Stent Placement Complications
 Bleedings
 Pain
 Perforation
 Bowel impaction
 Stent misplacement or migration
 Stent occlusion
 Tumor in-growth
 Tumor over-growth
 Stent fracture
 Fever

Foreign body sensation
 Death (other than that due to normal disease progression)
 Sepsis
 Acute cholecystitis
 Pancreatitis
 Cholangitis/Cholestasis
 Constipation
 Diarrhea
 Infection
 Liver abscess
 Peritonitis
 Sludge occlusion
 Ulcerations
7. Equipment required

Percutaneous Placement
·
0.035” (0.89mm) guidewire at least 180cm long (preferably stiff
or extra stiff)
· Introducer sheath appropriately sized for stent and introducer
system (7 Fr or larger-uncovered 8Fr-covered)
 Endoscopic Placement
·
0.035” (0.89mm) guidewire at least 450cm long (
preferably jag
wire)
· Introducer sheath appropriately sized for stent and introducer
system
· Endoscope system appropriately sized for instrument channel
(8Fr or larger uncovered and covered, 3.7mm working channel)
 Short-wire introducer system
· Short-wire locking device
· Endoscope with Minimum 3.2mm working channel.
· 0.035
’’
(0.89mm) stiff guidewire
8. Precautions
Read the entire User
’
s Manual thoroughly before using this
device. It should only be used by or under the supervision of
physicians thoroughly trained in the placement of stents. A
thorough understanding of the techniques, principles, clinical
applications and risks associated with this procedure is necessary
before using the device.
 Care should be taken when removing the introducer system and
guidewire immediately after stent deployment since this may
result in stent dislodgement if the stent has not been adequately
deployed.
 Care should be taken when performing dilation after the Stent
has been deployed as this may result in perforation, bleeding,
Stent dislodgement or Stent migration.
 The packaging and the device should be inspected prior to use.
 Use of fluoroscopy is recommended to ensure correct placement
of the device.
 Check the expiration date
“
Use by
”
. Do not use the device
beyond the use by date.
 The Niti-S & ComVi Stent is supplied sterile. Do not use if the
packaging is opened or damaged.
 The Niti-S & ComVi Stent is intended for single use only. Do
not resterilize and/or reuse the device.