WALLSTENT™ Self-Expanding Stent

Indications, Safety and Warnings


Wallstent RP Endoprosthesis

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.

INDICATIONS FOR USE/INTENDED USE

The WALLSTENT RP 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.

CONTRAINDICATIONS

The WALLSTENT RP Endoprosthesis is contraindicated for use in:

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

WARNINGS

  • 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.

PRECAUTIONS

  • Stenting across a major bifurcation may result in stenosis or occlusion of the nonstented vascular limb, and prevent or hinder future access for angioplasty procedures.
  • The safety and effectiveness of the WALLSTENT™ RP Endoprosthesis has not been established for use:
    • at a lesion site within a vascular graft or at the anastomosis
    • in patients for whom antiplatelet, anticoagulation therapy, or thrombolytic drugs are contraindicated or who exhibit coagulopathy
    • in pediatric patients
    • in total non-thrombotic chronic iliac artery occlusions

ADVERSE EVENTS

  • Thrombosis
  • Stent Misplacement
  • Bleeding Requiring Transfusion
  • Hematoma Requiring Repair
  • Distal Emboli
  • Pseudoaneurysm
  • Minor Hematoma
  • Intraluminal Thrombus
  • Cerebrovascular Incident
  • Death

Additional adverse events that have been reported to be associated with iliac stenting, although not observed in the clinical study include:

  • Vessel Rupture
  • Sepsis/Infection
  • AV Fistula Formation
  • Stent Migration
  • Need for Bypass or Amputation
  • Dissection

Transhepatic Biliary

INDICATIONS FOR USE/INTENDED USE

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Transhepatic Biliary are indicated for use in the treatment of biliary strictures produced by malignant neoplasms.

CONTRAINDICATIONS

Contraindications associated with the use of the WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Transhepatic Biliary include:

  • Use of the device in very small intrahepatic ducts.
  • 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 stent.
  • All of the customary contraindications associated with the percutaneous transhepatic manipulation of 6-9F (2.0-3.0 mm) caliber catheters (e.g.: bleeding disorders unresponsive to vitamin K or blood product therapy).

WARNINGS

  • The safety and effectiveness for use in the vascular system have not been established except for the following WALLSTENT product codes that are also indicated for improving central venous luminal diameter in the innominate and subclavian veins following unsuccessful angioplasty in patients on chronic hemodialysis with stenosis of the venous outflow tract: M001711320, M001711340, M001711360, M001711380, H965402110, H965402120, H965402130, H965402100.
  • 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 or misplacement of the entire stent into the duodenum may damage or obstruct the intestinal tract.

COMPLICATIONS

Complications associated with the use of the WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Transhepatic Biliary may include the usual complications reported for conventional biliary stents and transhepatic procedures such as infection, stent misplacement, stent migration, and stent obstruction secondary to tumor in-growth through the stent, tumor overgrowth at the stent ends, or sludge occlusion.

Tracheobronchial

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial are indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.

With the exception of the following WALLSTENT Codes which are approved for Venous or TIPS indications, the safety and effectiveness of this device for use in the vascular system has not been established and can result in serious harm and/or death: H965402100, H965402110, H965402120, H965402130, H965403100, H965403110, H965403120, H965403130, H965403300, H965403310, H965403320, H965403330, M001711320, M001711340, M001711360, M001711380.

CONTRAINDICATIONS

Contraindications associated with the use of the WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Tracheobronchial 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.

WARNINGS

  • Stenting across a major bifurcation may prevent or hinder future access or other procedures.
  • Use of the device across bifurcations 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 cricopharyngeus.
  • Use of a laser on or around the surface of the stent may result in damage to the stent.

COMPLICATIONS

Complications associated with the use of the WALLSTENT™ RP Endoprosthesis and WALLSTENT™ Endoprosthesis Tracheobronchial may include the usual complications reported for conventional tracheobronchial stents such as infection, stent misplacement, stent migration, and stent obstruction secondary to tumor or granuloma ingrowth through the stent, tumor or granuloma overgrowth at the stent ends, or mucous occlusion or perforation.

TIPS

INDICATIONS FOR USE/INTENDED USE

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis TIPS are 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.

CONTRAINDICATIONS

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis TIPS are contraindicated for use in:

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

WARNING

Treatment may exacerbate pulmonary hypertension or congestive heart failure in patients with severely compromised cardiovascular or pulmonary function.

PRECAUTIONS

  • A stent cannot be repositioned or removed after the deployment threshold has been exceeded.
  • Ultrasonographic or angiographic follow-up is recommended for post-TlPS monitoring of shunt status.

ADVERSE EVENTS

Adverse events recorded during the clinical trial of the WALLSTENTTIPS Endoprosthesis included:

  • Death – <30 days 15% & >30 days 15%
  • Intra-abdominal Hemorrhage secondary to: liver capsule/vessel puncture – 3%
  • Shock – 5%
  • Sepsis/Infection – 6%
  • Pulmonary hypertension/edema/Adult Respiratory Distress Syndrome – 1%
  • Hepatic Artery Thrombosis/Liver Failure – 1%
  • Shunt Stenosis or Occlusion – 17%
  • Hepatic or Portal Vein Occlusion or Stenosis – 1%
  • Encephalopathy – 30% increased
  • Puncture Site Hematoma – 1%
  • Recurrence of Esophageal Varices – 10%
  • Hyperbilirubinemia secondary to bile duct puncture – 1%
  • Hepatic Lobe Infarction – 1%

Additional adverse events associated with TIPS, although not observed in the clinical study include:

  • Stent Misplacement
  • Stent Migration
  • Disseminated Intravascular Coagulation
  • Pulmonary Embolism
  • Vessel Rupture
  • Pneumonia

The risks associated with the use of contrast media angiography (allergic type reactions, hypertension, shock, death) should also be considered, as fluoroscopy and angiography are recommended during the stent implant procedure. 

VENOUS

INDICATIONS FOR USE/INTENDED USE

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Venous are 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 ≤10 mm 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 RP Endoprosthesis and WALLSTENT Endoprosthesis Venous are the innominate and subclavian veins, ranging from 8.0 mm to 15 mm in diameter.

CONTRAINDICATIONS

The WALLSTENT RP Endoprosthesis and WALLSTENT Endoprosthesis Venous are contraindicated for use in patients with bleeding disorders unresponsive to vitamin K or blood product therapy.

WARNINGS

  • 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 materials should be of similar composition.
  • Proper stent sizing is critical to achieving adequate vessel apposition and avoiding possible stent migration. Refer to Table 1 for sizing information.

PRECAUTIONS

Stent Placement Precautions

  • 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 (e.g., surgery, further dilation, placement of additional stents, or other).

POTENTIAL ADVERSE EVENTS

Potential adverse events associated with use of the WALLSTENT Venous Endoprosthesis may include the usual adverse events reported for conventional percutaneous transluminal angioplasty such as: hemorrhage, infection, contrast media reactions, dissection, distal emboli, graft rupture, graft/vein thrombosis or occlusion, perforation of the vein, suture disruption of the anastomosis, thromboembolism or transient spasm. Potential adverse events associated with the WALLSTENT Venous Endoprosthesis are stent misplacement, stent migration, or vein perforation.

Carotid WALLSTENT™ Monorail™ Endoprosthesis

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.

INDICATIONS

The Carotid WALLSTENT Monorail Endoprosthesis (Carotid WALLSTENT Endoprosthesis), used in conjunction with the Boston Scientific embolic protection system, is indicated for the treatment of patients at high risk for adverse events from carotid endarterectomy due to either anatomic or comorbid conditions who require carotid revascularization in the treatment of ipsilateral or bilateral carotid artery disease and meet the criteria outlined below:

  • Patients with neurological symptoms and ≥50% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram OR patients without neurological symptoms and ≥80% stenosis of the common, internal carotid artery and/or the bifurcation by ultrasound or angiogram, AND
  • Patients with a reference vessel diameter within the range of 4.0 mm and 9.0 mm at the target lesion.

CONTRAINDICATIONS

The Carotid WALLSTENT Endoprosthesis is contraindicated for use in:

  • Patients in whom anticoagulant and/or antiplatelet therapy is contraindicated
  • Patients with severe vascular tortuosity or anatomy that would preclude the safe introduction of a guide catheter, sheath, embolic protection system or stent system
  • Patients with uncorrected bleeding disorders
  • Lesions in the ostium of the common carotid artery

WARNINGS

  • Refer to the Directions for Use supplied with any interventional devices to be used in conjunction with the Carotid WALLSTENT Endoprosthesis for their intended uses, contraindications, and potential complications.
  • The safety and efficacy of the Carotid WALLSTENT Endoprosthesis have not been demonstrated with embolic protection devices other than the FilterWire EZ™ System.
  • Risk of distal embolization may be higher if the Carotid WALLSTENT Endoprosthesis cannot be used in conjunction with an embolic protection system during the carotid stenting procedure.
  • The long-term performance of the Carotid WALLSTENT Endoprosthesis has not been established.
  • Stenting across a major bifurcation may hinder or prevent future diagnostic or therapeutic procedures.
  • In patients requiring the use of antacids and/or H2-antagonists before or immediately after stent placement, oral absorption of antiplatelet agents such as aspirin may be adversely affected.
  • The implantation of the Carotid WALLSTENT Endoprosthesis should be performed only under fluoroscopic observation with radiographic equipment providing high-resolution images.
  • Never advance the Carotid WALLSTENT Endoprosthesis without the guidewire extending from the tip.
  • Do not advance the Carotid WALLSTENT Endoprosthesis against significant resistance.
  • The Carotid WALLSTENT Endoprosthesis should be oversized in relation to the artery diameter by 1 mm to 2 mm to prevent migration.
  • Do not release the Carotid WALLSTENT Endoprosthesis if unusual force is required; in such a situation use another device.
  • Never advance a partially deployed Carotid WALLSTENT Endoprosthesis distally.
  • Reconstrainment and repositioning of the Carotid WALLSTENT Endoprosthesis should be strictly avoided when the partially deployed Carotid WALLSTENT Endoprosthesis is already in contact with the plaque of the stenosis.
  • Use of this device in patients with hypersensitivity to cobalt, chromium, iron, nickel, or molybdenum may provoke an allergic reaction.
  • Avoid using power injection in the cerebral circulation.

Device Use

  • Implanting a stent may lead to dissection of the vessel distal and/or proximal to the stent and may cause acute closure of the vessel, requiring additional intervention (carotid endarterectomy, further dilatation, or placement of additional stents).
  • The stent may cause a thrombus, distal embolization or may migrate from the site of implant down the arterial lumen. Appropriate sizing of the stent to the vessel is required to reduce the possibility of stent migration. In the event of thrombosis of the expanded stent, thrombolysis and PTA should be attempted.
  • In the event of complications such as infection, pseudoaneurysm or fistulization, surgical removal of the stent may be required.
  • Overstretching of the artery may result in rupture and lifethreatening bleeding.
  • Balloon angioplasty of the carotid bifurcation may initiate transient hemodynamic instability consisting of bradycardia or hypotension. Appropriate pharmacologic therapy must be immediately available.

PRECAUTIONS

Stent Handling

  • Do not hold the sheath or stent during stylus removal.

Stent Placement

  • The Carotid WALLSTENT Endoprosthesis is not compatible with any guidewire larger than 0.014 in (0.36 mm).
  • The Carotid WALLSTENT Endoprosthesis must be used with a guiding catheter or guiding sheath to maintain adequate support of the 0.014 in (0.36 mm) guidewire throughout the procedure.
  • For best device performance, the guidewire exit notch should remain within the guiding catheter or guiding sheath.
  • Ensure the stent system is fully flushed with heparinized saline prior to use. Do not use the delivery system if flush is not observed exiting at the distal end of the sheath.

Magnetic Resonance Imaging (MRI) Compatibility

Through non-clinical testing, the Carotid WALLSTENT MonorailR Endoprosthesis (Carotid WALLSTENT Endoprosthesis), has been shown to be MRI safe at field strengths of 3.0 Tesla or less, and a maximum whole body averaged specific absorption rate (SAR) of 2.0 W/kg for15 minutes of MRI exposure. The Carotid WALLSTENT Endoprosthesis should not migrate in this MRI environment. Non-clinical testing has not been performed to rule out the possibility of stent migration at field strengths higher than 3.0 Tesla. MRI at 3.0 Tesla or less may be performed immediately following the implantation of the Carotid WALLSTENT Endoprosthesis. MR image quality may be compromised if the area of interest is in the exact same area or relatively close to the position of the stent. MR image artifact has been evaluated at 1.5 Tesla only.

POTENTIAL ADVERSE EVENTS

Based on the literature, and on clinical and commercial experience with carotid stents and embolic protection systems, potential adverse events include, but are not limited to the following:

  • Abrupt vessel closure
  • Additional interventional or surgical treatment (e.g., stenting or carotid endarterectomy)
  • Allergic reactions (including to antiplatelet agents, contrast medium or stent materials)
  • Aneurysm
  • Angina/coronary ischemia
  • Arrhythmia
  • Arteriovenous fistula
  • Bacteremia or septicemia
  • Bleeding
  • Bradycardia
  • Cerebral vascular event such as edema
  • Cerebral ischemia/transient ischemic attack
  • Congestive heart failure (CHF)
  • Death
  • Detachment and/or implantation of a component
  • Emboli (air, tissue, plaque, thrombus, device or other)
  • Fever
  • Filter thrombosis/occlusion
  • Hematoma
  • Hemorrhage
  • Hyperperfusion syndrome
  • Hypotension/hypertension
  • Hypotonia
  • Infection
  • Ischemia/infarction of tissue or organ
  • Myocardial Infarction (MI)
  • Pain
  • Pseudoaneurysm
  • Renal failure/insufficiency
  • Restenosis of stented segment
  • Seizure
  • Severe unilateral headache
  • Stent embolization
  • Stent/filter entanglement or damage
  • Stent migration
  • Stent malposition
  • Stent thrombosis/occlusion
  • Stroke/cerebrovascular accident (CVA)
  • Vessel injury/dissection/perforation/rupture/trauma
  • Vessel occlusion or thrombosis
  • Vessel spasm or recoil

Any device related adverse event involving the Carotid WALLSTENT R Monorail Endoprosthesis (Carotid WALLSTENT Endoprosthesis) should be reported immediately to Boston Scientific, Customer Service, at (888) 272-1001.

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