Cordis OPTEASE® Retrievable
Vena Cava Filter

Essential Prescribing Information

Indications

The OPTEASE® Retrievable Vena Cava Filter is indicated for use in the prevention of recurrent pulmonary embolism (PE) via percutaneous placement in the 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 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 OPTEASE® Filter

Warnings for Filter Placement:

  • For single use only. DO NOT resterilize and/or reuse.
  • Do not exceed the maximum pressure rating of 800 psi when injecting contrast medium through the VISEASE® Angiographic Vessel Dilator
  • The OPTEASE® Filter is supplied constrained in a plastic storage tube indicating the appropriate orientation for femoral and jugular/antecubital approaches. Never reload a fully or partially ejected filter into the tube as this could result in incorrect orientation for the selected access site. Never reload a fully or partially ejected filter into the tube as this could affect its shape and function.
  • Filter fracture is a potential complication of vena cava filters. Anatomic locations that create concentrated stress points from filter deformation (for example, deployment at apex of scoliosis, overlapping of either of the renal ostia, or placement adjacent to a vertebral osteophyte) may contribute to fracture of a particular filter strut. However, reports of adverse clinical sequelae from filter fractures are rare.
  • Intended for use only by appropriately trained physicians.
  • Persons with allergic reactions to nickel titanium (nitinol) may suffer an allergic response to this implant.

Warnings for Filter Retrieval:

  • Excessive force should not be used to retrieve the filter.
  • Do not retrieve if thrombus is present in the filter and/or caudal to the filter.
  • Available data from retrievals in a 21 patient study and a 40 patient retrospective chart review suggest that the OPTEASE® Filter can be safely retrieved (mean of 11.1 days, range 5-14 days and mean of 16.4 days, range 3-48 days, respectively). Results demonstrate the OPTEASE® Filter can be safely retrieved up to 23 days.
  • Retrieval of the OPTEASE® Filter is possible only from femoral vein approach.
  • Intended for use only by appropriately trained physicians.
  • Never redeploy a retrieved filter.

Precautions

  • Do not expose to organic solvents.
  • The use of the OPTEASE® Filter with any accessory, other than those accompanying the device, could result in complications and/or an unsuccessful procedure.
  • Advancement, manipulation and withdrawal of the OPTEASE® Filter or its accessories should always be performed under fluoroscopic control.
  • If strong resistance is met during any stage of the procedure, discontinue the procedure and determine the cause before proceeding.
  • Through non-clinical testing, the OPTEASE® Filter has been shown to be MRI safe at field strengths of 3.0 Tesla or less, and a maximum gradient of 5 T/m, and a maximum whole body averaged specific absorption rate (SAR) of 4 W/Kg for 15 minutes of MRI. The OPTEASE® Filter should not migrate in this MRI environment. MRI at 3 Tesla or less may be performed immediately following the implantation of the filter. Non-clinical testing has not been performed to rule out the possibility of filter migration at field strengths higher than 3 Tesla. In testing, the OPTEASE® Filter produced a temperature rise of less than 1.8°C at a maximum whole body averaged specific absorption rate (SAR) of 4 w/Kg for 15 minutes of MRI. 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 filter.

Adverse Events

  • Possible placement procedure adverse events include, but are not limited to:
    • Air embolism
    • Hematoma at the puncture site
    • Incorrect positioning of the filter
    • Incorrect orientation of the filter
    • Perforation of the vessel wall
    • Restriction of blood flow
    • Occlusion of small vessel
    • Distal embolization
    • Infection
    • Intimal tear
    • Filter fracture
    • Thrombus formation
    • Filter obstruction
    • Filter perforation of the vena cava wall
    • Filter migration
    • Recurrent pulmonary embolism
  • Possible retrieval procedure complications include, but are not limited:
    • Air embolism
    • Hematoma at the puncture site
    • Rupture of the vessel wall
    • Perforation of the vessel wall
    • Intimal tear
    • Inability to retrieve the filter
    • Inability to push the retrieval catheter over the filter
    • Restriction of blood flow
    • Distal embolization
    • Infection
    • Filter fracture

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