Gastroenterology

Advanix™ Biliary Stent with NaviFlex™ RX Delivery System

Refer to the device directions for use for complete instructions on device use.

Intended Use/Indications for Use

The Advanix™ Biliary Stent with NaviFlex™ RX Delivery System is intended for delivery of the stent to the biliary tract for drainage of the bile duct, for splinting of a bile duct during healing, or for providing bile duct patentcy in a stricture or past a stone.

Contraindications

None known.

Adverse Events

Potential complications associated with Endoscopic Retrograde Cholangiopancreatography (ERCP) may include but may not be limited to:

• Allergic reaction to contrast medium
• Bile duct occlusion or obstruction
• Cholangitis
• Pancreatitis
• Stent migration
• Hemobilia
• Bile peritonitis
• Hematoma
• Hemorrhage
• Perforation of bile ducts, liver and/or duodenum
• Septicemia/infection

Precautions

• When long-term use is necessary, the stent should be evaluated for replacement at three-month intervals. This stent is not intended for use as a permanent implant.
• Check for proper position of the stent and delivery system using endoscopy and fluorscopy. Insertion and placement in an improper location may lead to patient injury.
• If resistance is met during the procedure, do not advance the guidewire or the Advanix Biliary Stent with NaviFlex RX Delivery System without first determining the cause of resistance and taking remedial action.
• The Advanix Biliary Stent with NaviFlex RX Delivery System should only be used by or under the supervision of physicians thoroughly trained in endoscopic biliary procedures. A thorough understanding of the technical principles, clinical applications, and risks associated with endoscopic biliary stent procedures is necessary before using this device.
• Any use of procedures other than those indicated in these instructions is not recommended.
• It is recommended that repositioning of the stent occurs prior to the change in color on the pull wire.

Perscriptive Information

Indications for Use

The device is indicated for the palliative treatment of Colonic strictures produced by malignant neoplasm and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.

Contraindications

Contraindications associated with the use of the WallFlex™ Colonic Stent System with Anchor Lock Delivery System include:

• Enteral ischemia
• Suspected or impending perforation
• Intra-abdominal abscess/perforation
• Strictures that do not allow passage of a guidewire
• Patients for whom endoscopic techniques are contraindicated
• Any use other than those specifically outlined under indications for use

Warnings

• The device should be used with caution and only after careful consideration in patients with elevated bleeding times, coagulopathies, or in patients with radiation colitis or proctitis.
• Stents cannot be repositioned after complete deployment.
• The safety and effectiveness of this device for use in benign strictures have not been established.
• Chemoradiation therapy or radiotherapy alone may lead to tumor shrinkage and subsequent stent migration.
• The stent contains nickel, which may cause an allergic reaction in individuals with nickel sensitivity.
• To minimize pain and tenesmus, the proximal stent end should be placed 2 cm above the anal canal or 6 cm from the anus.

Precautions

• Read the entire directions for use thoroughly before using the WallFlex Colonic Stent System with Anchor Lock Delivery System. The WallFlex Colonic Stent System with Anchor Lock Delivery System should only be used by or under the supervision of physicians thoroughly trained in the placement of colonic stents. A thorough understanding of the techniques, principles, clinical applications and risks associated with this procedure is necessary before using the device.
• The system must not be resterilized.
• The packaging and the device should be inspected prior to use. Do not use the device if the product is damaged in shipping.
• The device is intended for single use only. Do not attempt to reload deployed stents onto the delivery system.
• Use of fluoroscopy is recommended. Not using fluoroscopy can result in misplacement of the stent.

MR Conditional

Non-clinical testing has demonstrated that the WallFlex™ Colonic Stent System with Anchor Lock Delivery System is MR Conditional. A patient with this device may undergo MRI immediately under the following conditions:

• static magnetic field of 3 Tesla or less
• maximum spatial magnetic gradient field of 720 Gauss/cm or less
• maximum whole body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of scannings

In non-clinical testing, the WallFlex Colonic Stent System with Anchor Lock Delivery System produced a temperature rise of less than or equal to 0.6°C at a maximum whole body averaged specific absorption rate (SAR) of 3 W/kg for 15 minutes of MR scanning in a 3 Tesla Excite®, G3.0-052B, General Electric Medical Systems, Milwaukee, WI; active-shielded, horizontal field MR scanner. MR image quality may be compromised if the area of interest is in the same area or relatively close to the position of the WallFlex Colonic Stent System with Anchor Lock Delivery System.

Adverse Events

Complications associated with the use of the WallFlex Colonic Stent System with Anchor Lock Delivery System may include:
Procedural Complications

• Bleeding
• Pain
• Stent misplacement or inadequate expansion
• Intestinal perforation
• Death

Post Stent Placement Complications

• Bleeding
• Perforation
• Pain
• Stent migration
• Stent occlusion due to tumor in-growth through stent
• Stent occlusion due to tumor over-growth around ends of stent
• Stent occlusion
• Foreign body sensation
• Bowel impaction
• Ulceration
• Fever
• Septicemia
• Death (other than that due to normal disease progression)
• Infection
• Diarrhea
• Constipation
• Peritonitis
• Symptoms of tenesmus or urgency/incontinence

Prescriptive Information

Refer to the Directions for Use for complete instructions for use.

Indications
The WallFlex Esophageal Partially Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

Contraindications
The WallFlex Esophageal Partially Covered Stent System is contraindicated for:

• Placement in esophageal strictures caused by benign tumors, as the long-term effects of the stent in the esophagus are unknown.
• Placement in strictures that cannot be dilated enough to pass the endoscope or the delivery system.
• Placement of the proximal end of stent within 2 cm of the cricopharyngeal muscle.
• Placement in an esophago-jejunostomy (following gastrectomy), as peristalsis and altered anatomy may displace stent.
• Placement in necrotic chronically bleeding tumors, if bleeding is active at the time of placement.
• Placement in polypoid lesions.
• Those patients for whom endoscopic techniques are contraindicated.
• Any use other than those specifically outlined under indications for use.
• Placement in patients who have an underlying bleeding diathesis.

Warnings
The WallFlex Esophageal Stent System should be used with caution and only after careful consideration in patients with:

• Strictures exceeding 12 cm in length
• Significant preexisting pulmonary or cardiac disease

Potential Adverse Effects
The potential adverse effects associated with esophageal stent placement may include:

• Bleeding
• Perforation
• Pain
• Aspiration
• Stent migration
• Tumor ingrowth through uncovered portion of stent
• Tumor overgrowth around stent ends
• Foreign body sensation
• Food bolus impaction
• Reflux
• Esophagitis
• Edema
• Ulceration
• Fever
• Infection
• Sepsis
• Septicemia
• Recurrent dysphagia
• Fistula formation
• Tracheal compression/obstruction (or acute airway compression)
• Hematemesis
• Death (other than that due to normal disease progression)

Possible Post Stent Complications

• Sensitivity to the metal component of the stent
• Mediastinitis
• Aspiration
• Intestinal obstruction (secondary to stent migration)

Instructions in the Event of Damage
Warning: Visually inspect the system for any signs of damage. Do not use if the system has any visible signs of damage. Failure to observe this warning may result in patient injury.
CAUTION: Federal (USA) law restricts this device to sale by or on the order of a physician.