Cordis TRAPEASE® Permanent
Vena Cava Filter

Essential Prescribing Information

Indications

The TRAPEASE® Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the inferior vena cava in the following situations:

  • Pulmonary thromboembolism when anticoagulants are contraindicated
  • Failure of anticoagulant therapy in thromboembolic diseases
  • Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced
  • Chronic, recurrent pulmonary embolism where anticoagulant therapy has failed, or is contraindicated
  • The VISEASE® Angiographic Vessel Dilator is designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to the vena cava

Contraindications

  • Patients with risk of septic embolism
  • Patients with uncontrolled infectious disease
  • Patients with an IVC diameter larger than 30 mm
  • Patients contraindicated for procedures under fluoroscopy
  • Patients with demonstrated hypersensitivity to one of the components of the TRAPEASE® Filter

Warnings

  • For single use only. DO NOT resterilize and/or reuse.
  • TRAPEASE® Filter is MRI-compatible; MRI-safe, and neither interferes with nor is affected by the operations of an MRI device.
  • Do not exceed the maximum pressure rating of 800 psi when injecting contrast medium through the VISEASE® Angiographic Vessel Dilator
  • Any catherization procedure requiring passage of a device through the filter may be impeded.
  • The TRAPEASE® Filter is supplied constrained in a plastic storage tube. Never reload a fully or partially ejected filter into the tube as this could affect its shape and function.
  • Intended for use only by appropriately trained physicians.
  • Persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.

Precautions

  • Do not autoclave.
  • Do not expose to organic solvents.
  • The use of the TRAPEASE® Filter with any accessory, other than those accompanying the device, could result in complications and/or an unsuccessful procedure.
  • If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.

Adverse Events

  • Intimal tear
  • Thrombus formation
  • Filter obstruction
  • Filter perforation of the vena cava wall
  • Filter migration
  • Filter fracture
  • Recurrent pulmonary embolism

CAUTION: Federal (USA) law restricts these devices to sale by or on the order of a physician.
See package insert for full product information.