WallFlex Biliary Transhepatic Stent System

Combined abbreviated statement for WallFlex Transhepatic Fully Covered, Partially Covered and Uncovered

CAUTION: Federal law (USA) restricts this device to sale by or on the order of a physician. Rx only. Prior to use, please see the complete “Directions for Use” for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events, and Operator’s Instructions.

INTENDED USE/INDICATIONS FOR USE

The WallFlex Biliary Transhepatic Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.

CONTRAINDICATIONS

The WallFlex Biliary Transhepatic Stent System is contraindicated for:

• Stenting of a perforated duct (specific to WallFlex Biliary Transhepatic FC and PC stents)
• Stenting of a perforated duct where leakage from the duct could be exacerbated by the prosthesis and leakage could occur across the mesh of the uncovered stent. (specific to WallFlex Biliary Transhepatic UC stents
• All of the customary contraindications associated with the percutaneous transhepatic manipulation of introducer sheaths and delivery systems (e.g., bleeding disorders unresponsive to Vitamin K or blood product therapy).
• Placement in biliary strictures caused by benign tumors, as the long-term effects of the stent in the bile duct is unknown.
• Placement in strictures that cannot be dilated enough to pass the delivery system.
• Placement in very small intrahepatic ducts.
• Any use other than those specifically outlined under indications for use.

WARNINGS

• 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.
• Passing a second stent delivery system through a just deployed stent is not recommended and could cause the stent to dislodge.
• Use caution when placing fully covered, partially covered, or uncovered stent near ductal branches to avoid obstruction of duct. Placement of a fully covered or partially covered biliary stent across a branch duct or major bifurcation may result in complications due to blockage of flow from the branch duct and prevent endoscopic or transhepatic access for future procedures.
• Stenting across a major bifurcation may prevent or hinder future endoscopic access or other procedures.
• A stent cannot be reconstrained after the reconstrainment limit has been exceeded. Stent reconstrainment can be completed twice, allowing a total of three deployment attempts.
• The WallFlex Biliary Transhepatic stent should not be moved or removed during the procedure. Manipulating, repositioning or removal of the stent may result in perforation, bleeding, tissue abrasion or other patient injury.
• The WallFlex Biliary Transhepatic stent should not be moved or removed after completion of the initial stent placement procedure in intrinsic malignant tumors. Manipulating, repositioning or removal of the stent may result in perforation, bleeding, tissue abrasion or other patient injury.
• Final stent placement resulting in an excessive length of stent protruding into the duodenum or misplacement of the entire stent into the duodenum may damage or obstruct the intestinal tract.
• Specific to FC and PC WallFlex Biliary Transhepatic stents, careful consideration must be taken when removing a stent from an intrinsic malignant tumor. Removal may result in perforation, bleeding or tissue abrasion.
• Attempts to remove a partially deployed stent through the liver could cause significant bleeding.
• The safety and effectiveness of this device for use in the vascular system have not been established.
• NO WARRANTY IS MADE WITH REGARD TO REMOVABILITY OF THIS DEVICE BY ENDOSCOPIC MEANS OR OTHERWISE.

PRECAUTIONS

• Read the entire Directions for Use thoroughly before using the WallFlex Biliary Transhepatic Stent System.
• The WallFlex Biliary Transhepatic Stent System should only be used by or under the supervision of physicians thoroughly trained in biliary prosthesis placement. A thorough understanding of the technical principles, clinical applications, and risks associated with this procedure is necessary before using this device.
• The sterile packaging and device should be inspected prior to use. If sterility or performance of the device is suspected to be compromised, it should not be used.
• The device is intended for single use only. Do not attempt to reload deployed stents onto the delivery system.
• Excessive force should not be used to position or deploy the stent. This may cause inadvertent damage to the device and injury to the patient.

ADVERSE EVENTS

Potential Complications associated with the use of the WallFlex Biliary Transhepatic Stent System may include the usual complications reported for metal stent placement and transhepatic procedures such as:

• Stent occlusion due to tumor overgrowth, tumor ingrowth, granulation tissue or sludge formation
• Perihepatic bile leak or hematoma
• Re-intervention due to occlusion
• Hemobilia
• Sepsis
• Pain
• Hemorrhage
• Fever
• Nausea
• Vomiting
• Infection
• Inflammation
• Recurrent obstructive jaundice
• Mucosal hyperplasia
• Cholangitis
• Cholecystitis
• Pancreatitis
• Ulceration of duodenum or bile duct
• Perforation of duodenum or bile duct
• Stent migration or dislodgement
• Death (other than that due to normal disease progression)
• Stent misplacement
• Stent fracture
• Hepatic abscess
• Specific to WallFlex Biliary Transhepatic FC stent, perforation of the gallbladder due to the stent covering the cystic duct