WALLSTENT® Endoprosthesis

Prescriptive Information

Prior to use please see the complete 'Directions for Use' for more information on Indications, Contraindications, Warnings, Precautions, Adverse Events and Operator's Instructions.

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Indications

Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Iliac Endoprosthesis is indicated for use following suboptimal percutaneous transluminal angioplasty (PTA) of common and/or external iliac artery stenotic lesions, which are > 10 cm in length. A suboptimal PTA is defined as a technically successful dilation, judged by the physician to be suboptimal due to the presence of unfavorable lesion morphology such as:

• An inadequate angiographic and/or hemodynamic result as defined by a 30% or greater residual stenosis after PTA, lesion recoil, or intimal flaps.
• Flow limiting dissections post PTA longer than the initial lesion length.
• A 5 mm Hg or greater mean transtenotic pressure gradient post PTA.

Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent TIPS Endoprosthesis is indicated for creation of intrahepatic shunt connections between the portal venous system and the hepatic vein for prophylaxis of variceal bleeding in the treatment of portal hypertension and its complications in patients who have previously failed conventional treatment techniques.

Wallstent® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures or fistulas produced by malignant neoplasms, or in benign strictures or fistulas after all alternative therapies have been exhausted.

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Venous Endoprosthesis is indicated for improving central venous luminal diameter following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract. Unsuccessful angioplasty is defined as residual stenosis ≥ 30& for a vein ≤ 10mm in diameter or ≥ 50& for a vein > 10 mm in diameter, a tear which interrupts the integrity of the intima or lumen, abrupt lesion site occlusion, or refractory spasm. The vessels that can be treated with the Wallstent Venous Endoprosthesis are the innominate and subclavian veins, ranging from 8.0 mm to 15 mm in diameter.

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Contraindications

Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Plus Delivery System
Contraindications associated with the use of the Wallstent Transhepatic Biliary Endoprosthesis include:

• Use of the device in very small intrahepatic ducts.
• Stenting of a perforated duct, where leakage from the duct could be exacerbated by prosthesis and leakage could occur across the mesh of the stent.
• All of the customary contraindications associated with the percutaneous transhepatic manipulation of 8-9F caliber catheters (e.g. bleeding disorders unresponsive to vitamin K or blood product therapy).

Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Iliac Endoprosthesis is contraindicated for use in:

• Patients who exhibit persistent acute intraluminal thrombus at the proposed standing site, post thrombolytic therapy.
• Patients who experience the complication of arterial perforation or a fusiform of sacciform aneurysm during the procedure preceding possible stent implantation.

Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent TIPS Endoprosthesis is contraindicated for use in:

• Patients with associated occlusion of the portal or hepatic vein.
• Patients with gastric varices secondary to splenic vein thrombosis.

Wallstent® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System
Contraindications associated with the use of the Wallstent Tracheobronchial Endoprosthesis include:

• Use of the device in very small bronchials which could impede catheter removal.
• All of the customary contraindications associated with the manipulation of catheters within the tracheobronchial system.

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System
The Wallstent Venous Endoprosthesis is contraindicated for use in: patients with bleeding disorders unresponsive to vitamin K or blood product therapy.

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Warnings

Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Plus Delivery System

• The safety and effectiveness for use in the vascular system have not been demonstrated for this device model.
• Stenting across a major bifurcation may prevent or hinder future endoscopic access or other procedures.
• Stents cannot be repositioned after the deployment threshold has been exceeded.
• Final stent placement resulting in an excessive length of stent protruding into the duodenum may damage or obstruct the intestinal tract.

Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery System

• Care should be taken during stent deployment to avoid stent placement beyond the iliac ostium into the aorta as this may result in thrombus formation.
• A stent cannot be repositioned or removed after the deployment threshold has been exceeded.

Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery System
Treatment may exacerbate pulmonary hypertension or congestive heart failure in patients with severely compromised cardiovascular or pulmonary function.

Wallstent® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System

• The safety and effectiveness for use in the vascular system have not been demonstrated for this device model.
• Stenting across a major bifurcation may prevent or hinder future access or other procedures.
• Use of this device across bifurcation or side branches could impede airflow to the affected portion of the lung.
• Stents cannot be repositioned after the deployment threshold has been exceeded.
• Stents should not be placed near or across the caudal aspect of the cricoid cartilage.
• Use of laser on or around the surface of the stent may result in damage to the stent.

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System

• Subsequent restenosis may require repeat dilation of the vessel segment containing the stent. The long-term outcome following repeat dilation of venous stents is unknown at present.
• When multiple stents are required, stent material should be of similar composition.
• Proper stent sizing is critical to achieving adequate vessel apposition and avoiding possible stent migration.

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Potential Adverse Effects

Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Plus Delivery System
Infection, Stent misplacement, Stent migration, Stent obstruction secondary to tumor ingrowth through the stent, tumor overgrowth at the stent ends, or sludge occlusion.

Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery System
Thrombosis, Stent misplacement, Bleeding requiring transfusion, Hematoma requiring repair, Distal emboli, Pseudoaneurysm, Minor hematoma, Intraluminal thrombus (subtotal), Cerebrovascular incident, Death, Vessel rupture, Sepsis/infection, AV fistula formation, Stent migration.

Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery System
Death, Intra-abdominal hemorrhage secondary to liver capsule/vessel puncture, Shock, Sepsis/Infection, Pulmonary hypertension/edema/adult respiratory distress syndrome, Hepatic artery thrombosis/liver failure, Shunt stenosis or occlusion, Hepatic or portal vein occlusion or stenosis, Encephalopathy, Puncture site hematoma, Recurrence of esophageal varices, Hyperbilirubinemia secondary to bile duct puncture, Hepatic lobe infarction, Stent misplacement, Stent migration, Disseminated intravascular coagulation, Pulmonary embolism, Vessel rupture, Pneumonia.

Wallstent® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System
Infection, Stent misplacement, Stent migration, Stent obstruction secondary to tumor or granuloma ingrowth through the stent, tumor or granuloma overgrowth at the stent ends, or mucous occlusion or perforation.

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System
Hemorrhage, Infection,Contrast media reactions, Dissection, Distal emboli, Graft rupture, Graft occlusion/restenosis, Graft/vein thrombosis or occlusion, Perforation of the vein, Suture disruption of the anastomosis, Thromboembolism, Transient spasm, Stent misplacement, Stent migration, Vein perforation, Death, Surgical revision, Pseudoaneurysm, Hematoma, Edema, Stent restenosis, Stent thrombosis.

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Cautions

Wallstent® Transhepatic Biliary Endoprosthesis with Unistep™ Plus Delivery System
Stenting across a major bifurcation may result in stenosis or occlusion of the non-stented vascular limb, and prevent or hinder future access for angioplasty procedures. The device is intended for use by physicians who have received appropriate training in interventional techniques and placement of intravascular stents.

Wallstent® Iliac Endoprosthesis with Unistep™ Plus Delivery System
Stenting across a major bifurcation may result in stenosis or occlusion of the non-stented vascular limb, and prevent or hinder future access for angioplasty procedures. Safety and effectiveness for use in total nonthrombotic iliac artery occlusions has not been established. Safety and effectiveness in patients for whom antiplatelet, anticoagulation therapy, or thrombolytic drugs are contraindicated or who exhibit coagulopathy has not been established. Safety and effectiveness for use in pediatric patients has not been established. Safety and effectiveness for use at a lesion site within a vascular graft or at the anastomosis has not been established.

Wallstent® TIPS Endoprosthesis with Unistep™ Plus Delivery System
A stent cannot be repositioned or removed after the deployment threshold has been exceeded.

Ultrasonographic or angiographic follow-up is recommended for post-TIPS monitoring of shunt status.

Wallstent® Tracheobronchial Endoprosthesis with Unistep™ Plus Delivery System
Stenting across a major bifurcation may result in stenosis or occlusion of the non-stented vascular limb, and prevent or hinder future access for angioplasty procedures. The device is intended for use by physicians who have received appropriate training in interventional techniques and placement of intravascular stents.

Wallstent® Venous Endoprosthesis with Unistep™ Plus Delivery System
Do not advance a partially (≤ 50%) deployed stent. A stent cannot be repositioned after the deployment threshold has been exceeded. Implanting a stent may lead to dissection of the vessel distally, and/or proximally, to the stented portion, and may cause acute closure of the vessel requiring additional intervention.

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Trademark

WALLSTENT is a registered trademark of Boston Scientific Corporation or its affiliates.