Ultraflex™ Tracheobronchial Stent System

Prescriptive Information

Refer to the operator's manual for complete instructions for use.

Indications

The Ultraflex Tracheobronchial Stent System is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

Warnings

The safety and effectiveness of this device for use in the vascular system has not been established and can result in serious harm and/or death.

For single use only. Do not reuse, reprocess or sterilize. Reuse, reprocessing or sterilization may compromise the structural integrity of the device and/or lead to device failure which, in turn, may result in patient injury, illness or death. Reuse or reprocessing may also create a risk of contamination of the device and/or cause patient infection or cross-infection, including, but not limited to, the transmission of infectious disease(s) from one patient to another. Contamination of the device may lead to injury, illness or death of the patient.

Contraindications

The Ultraflex Tracheobronchial Stent System is contraindicated for concurrent fistula of the tracheobronchial tree, unless a covered stent is being used; tracheobronchial obstruction with a luminal diameter which cannot be dilated to and maintained at least 4mm, or preventing passage of either a rigid or flexible bronchoscope; for patients for whom bronchoscopic procedures are contraindicated; and for any use other than those specifically outlined under the Indications for Use.

Potential Complications

Procedural Complications:
Potential adverse effects may include, but are not limited to, stent misplacement, bleeding, tracheobronchial perforation and pneumothorax, pain, aspiration, oxygen desaturation related to sedation or procedural instrumentation infection, and infection.

Post-stent Placement Complicatons:
Potential adverse effects may include, but are not limited to: halitosis, stent migration, stent occlusion due to mucous accumulation, stent occlusion due to tumor ingrowth, stent occlusion due to tumor overgrowth of stent ends, stent occlusion due to granulomatous tissue ingrowth, restenosis due to granulomatous tissue formation at stent ends, recurrent obstructive dyspnea related to stent occlusion or migration, tracheobronchial wall ulceration and/or perforation and/or hemorrhage, infection and septic shock, aphonia, death, stent fracture, and obstructive atelectasis (even with a well-positioned stent).

Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this device should only be used by persons qualified in the procedures for which it is indicated.

Cautions

The Ultraflex Tracheobronchial Stent System should be used with caution and only after careful consideration in patients with:

• Elevated bleeding times or coagulopathies
• Prior pneumonectomy
• Concurrent acute inflammation in the lumen, as this may potentiate granuloma formation and fibrosis
• A tumor stricture adjacent to a major vessel, as this may potentiate fistula formation
• Placement of an improperly sized stent can lead to a higher incidence of granulation tissue formation
• Placement of any type of stent in the subglottic trachea is associated with a higher rate of granuloma formation and should be avoided
• The Ultraflex Tracheobronchial Stent is made of Nitinol, an alloy of nickel and titanium, which may cause an allergic reaction in individuals with nickel sensitivity
• Laser ablation to treat excessive granulation tissue post stent placement may result in loss of stent integrity and/or cause airway fire
• This product contains no detectable latex

Cautions can be found in the product labeling supplied with each device. CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.