Taewoong Niti-S Nagi Stent Manual Del Usuario página 4

6. 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 Nagi™ Stent is supplied sterile. Do not use if the packaging is opened or
damaged.

The Niti-S Nagi™ Stent is intended for single use only. Do not resterilize and/or
reuse the device.
7. 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.
8. Potential Complications
Potential complications associated with the use of Niti-S Nagi™ Stent may include, but
are not limited to:
Procedural Complications

Bleeding

Stent misplacement

Inadequate expansion

Migration

Pain

Perforation
Post Stent Placement Complications

Bleeding

Pain

Perforation

Stent dislocation

Stent misplacement or migration

Stent occlusion

Fever

Pancreatitis

Abscess formation

Haemorrhage

Vomiting

Pneumoperitoneum

Intraperitoneal leakage

Peritonitis

Hematoma

Inflammation or Infection

Fistula

Ulceration

Sepsis

Rupture of intracystic artery

Stent removal failure
9. Equipments Required
⚫ Percutaneous Placement
Percutaneous placement has not been established yet.
⚫ Endoscopic Placement

0.035" (0.89mm) guidewire at least 450cm long

Echoendoscope or therapeutic duodenoscope with instrument channel of 3.7mm or
larger

Needle

Needle knife and/or balloon catheter

Stent

Forceps and/or Snare
10. Procedure
- (50cm introducer usable length)
Percutaneous procedure has not been established yet.
- (180cm introducer usable length)
Endoscopy Ultrasound (EUS) should be performed prior to placement of the Niti-S
Nagi™ Stent to characterize the extent of the lesion and its morphology.