Polyflex® Airway Stent

Prescriptive Information

Indications

Indicated for compression or strictures due to tumors (trachea and main bronchus), stenosis of the central airways (such as trachea and main bronchus), tracheoesophageal fistula, and airway complications such as anastomosis and stenosis.

Contraindications

• None in life threatening emergencies
• Obstruction of the Larynx
• Narrow or rigid stenoses that cannot be dilated sufficiently
• Patients for whom endoscopic techniques are contraindicated
• Patients with blood clotting disorders
• Bilateral recurrent laryngeal nerve paresis

Relative contraindications include: operable tracheomalacia and benign operable stenosis.

Warnings

For single use only. Do not reuse, reprocess or resterilize. Reuse, reprocessing or resterilization 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, reprocessing or resterilization 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.

After use, dispose the stent loader/soft positioner, delivery tube, stopper and packaging in accordance with hospital, administrative, and/or local government policy.

The Polyflex Airway stent system should be used with caution and only after careful consideration in patients with: elevated bleeding time or coagulopathies, prior pneumanectomy, concurrent acute inflammation in the lumen, as this may potentiate granuloma formation and fibrosis, or a tumor stricture adjacent to a major vessel, as this may potentiate fistula formation.

Potential Complications

Literature states the following list of possible complications in connection with the use of airway stents. Please refer to current literature for currect complications.

Complications during the procedure: mucosal damage, pain, bleeding, perforation, failure of stricture dilation by the stent, aspiration, hypoxia, stent misplacement, and pneumothorax.

Complications after the stent placement: pain, bleeding, perforation, stent migration, foreign body sensation, stent occlusion due to tumor overgrowth or granulation tissue or mucus (incrustation), mucus retention, infection by bacteria or fungi, pneumonia, edema, fever, development of fistula, sepsis, halitosis, recurrent obstructive dyspnea, aphonia, obstructive atelectasis, and death.

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

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.