Essential Prescribing Information
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
- 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
- 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.
- 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.
- 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.