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WALLSTENT™ Endoprosthesis

Indications, Safety and Warnings


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Wallstent RP Endoprosthesis Iliac

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.

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