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Idiomas disponibles
Idiomas disponibles
Niti-S Full Covered Stent cannot be removed when there is
tumor in-growth/over-growth/occlusion of the Stent lumen.
Full Covered Stent may be repositioned immediately after
deployment; see 12. Instructions for Removal of Full Covered
Stents.
Uncovered/bare Stents should not be removed once fully
deployed; see Contraindications.
Do not attempt to recapture/reload a stent once its deployment is
advanced.
6. Potential complications
Potential complications associated with the use of Niti-S &
ComVi Stent may include, but are not limited to:
Procedural Complications
Bleeding
Stent misplacement or inadequate expansion
Pain
Death (Other than due to normal disease progression)
Aspiration
Post Stent Placement Complications
Bleeding
Pain
Perforation
Stent misplacement or migration
Stent occlusion
Tumor overgrowth
Tumor ingrowth
Fever
Foreign body sensation
Death (other than that due to normal disease progression)
Sepsis
Acute angulations
Pneumonias
Haematemesis
Airway Compressions
Reflux
Food bolus impaction (lavage and debridement may be
necessary on a periodic basis)
Esophagitis
Dysphagia
Esophagobronchial fistula
Ulcerations
Aspirations
7. Equipment required
Distal or Proximal Release Introducer
Fluoroscope and/or endoscope
0.038"/ 0.97 mm guidewire
Introducer sheath appropriately sized for stent and introducer
system
TTS Introducer
0.035" (0.89mm) guidewire (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)
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.
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