Taewoong ComVi, User Manual

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· Niti-S Full Covered Stent cannot be removed when there is
tumor in-growth/over-growth/occlusion of the Stent lumen.
· Full Covered Stent can be repositioned immediately after
deployment.
· 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 the colon stent
may include, but are not limited to:
Procedural Complications
· Bleeding
· Stent misplacement or inadequate expansion
· Pain
· Death (other than that due to normal disease progression)
· Intestinal Perforation
Post Stent Placement Complications
· Bleeding
· Pain
· Perforation
· Bowel impaction
· Stent misplacement or migration
· Stent occlusion
· Tumor overgrowth
· Tumor ingrowth
· Fever
· Foreign body sensation
· Death (other than that due to normal disease progression)
· Sepsis
· Constipation
· Diarrhea
· Infection
· Peritonitis
· Ulceration
· Symptoms of tenesmus or urgency/incontinence
7. Equipment required
· Fluoroscope and/or Endoscope (with a channel size of 3.7 mm
or greater)
· 0.035 in/ 0.89 mm guidewire (TTS)
· 0.038 in/ 0.97 mm guidewire (OTW; Distal & Proximal release)
· 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.