Dynamic™ (Y) Stent

Prescriptive Information

Indications

• Airway complications such as anastomosis and stenosis following lung transplantation
• Tracheo-malacia
• Tracheo-esophageal fistula

Contraindications

• None in life threatening emergencies
• Laryngeal obstruction
• Bilateral paralysis of recurrent laryngeal nerve
• Patent tracheal stoma
• Need for artificial ventilation

Warnings

Do not use if package is damaged. If damage is found, call your Boston Scientific representative.

For single patient 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 of product and packaging in accordance with hospital, administrative and/or local government policy.

Do not use on patients with:

• Operable stenosis
• Mature, open tracheostoma
• Patients who need artificial respiration because of indications other than stenosis
• Compression of airway by vascular anomalies (e.g. aortic aneurysm)

Potential Adverse Effects

Please be aware that potential adverse effects may arise even with the proper use of medical devices. Accordingly, this stent is designed for use by a physician trained in stent insertion of tracheobronchial stents under laryngoscopic, or rigid bronchoscopy.

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.