Taewoong Niti-S Tracheal Uncovered Stent Manual Del Usuario página 5

Post Stent Placement Complications
· Bleeding
· Pain
· Perforation
· Stent migration
· Stent occlusion
· Tumor overgrowth
· Tumor ingrowth
· Death (other than that due to normal disease progression)
· Fever
· Foreign body sensation
· Sepsis
· Infection
· Edema
· Pneumothorax
· Halitosis
· Hemoptysis
· Restenosis
· Dyspnea
· Stent fracture
· Hypoxia
· Cough
· Granulation tissue formation
· Stent misshaping
· Tracheoesophageal fistula
7. Equipment required
· Fluoroscope and/or Endoscope
· 0.035" / 0.89 mm guidewire (12Fr. or less)
· 0.038" / 0.97 mm guidewire (14Fr. or more)
· Introducer sheath appropriately sized for stent and introducer
system
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 Stent is supplied sterile. Do not use any the
packaging is opened or damaged.
· The Niti-S Stent is intended for single use only. Do not
resterilize and/or reuse the device.
9. Instructions in the event of Damage
WARNING: Visually inspect the system for any sign of damage.
DO NOT USE if the system has any visible signs of damage.
Failure to observe this precaution may result in patient injury.
10. Procedure
Examine stricture endoscopically and fluoroscopically
a) Carefully examine both the proximal and distal segment of
stricture endoscopically and/or fluoroscopically.