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Idiomas disponibles
Idiomas disponibles
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.
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