The TRAPEASE® Filter is indicated for the prevention of recurrent pulmonary embolism 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 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.
The TRAPEASE® Filter should not be implanted in:
- 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. There are no known contraindications for use of the Angiographic Vessel Dilator.
- Risk of re-use. This product is designed and intended for single use. It is not designed to undergo reprocessing and resterilization after initial use. Reuse of this product, including after reprocessing and/or re-sterilization, may cause a loss of structural integrity which could lead to a failure of the device to perform as intended and may lead to a loss of critical labeling/use information all of which present a potential risk to patient safety.
- When injecting contrast medium through the Angiographic Vessel Dilator, do not exceed the maximum pressure rating of 800 psi. Ensure that a high pressure connection line is used.
- After filter implantation, any catheterization procedure requiring passage of a device through the filter may be impeded.
- The TRAPEASE® Filter is supplied contained in a plastic storage tube. Never reload a (partially) ejected filter into the tube as this could affect its shape and function. Accordingly, Cordis will not be responsible for any direct, incidental or consequential damages resulting from replacement of the TRAPEASE® Filter in the plastic storage tube.
- 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.
- The TRAPEASE® Filter should only be used by physicians who are trained in diagnostic and percutaneous interventional techniques, for instance placement of vena cava filters. Accordingly, Cordis will not be responsible for any direct or consequential damages or expenses resulting from use by untrained personnel.
- Persons with allergic reactions to nickel titanium (Nitinol) may suffer an allergic response to this implant.
- Store in a cool, dark, dry place.
- Do not use if package is open or damaged.
- Use prior to “Use By” date.
- Do not resterilize by any other method. Do not expose to temperatures above 54°C (130°F) for any length of time.
- Do not expose to organic solvents.
- The TRAPEASE® Filter has been tested and qualified with the accompanying accessories. The use of any other accessory 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.
- The TRAPEASE® Filter has been shown to be MRI safe at field strengths of 3.0 Tesla or less, 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 through non-clinical testing. The TRAPEASE® 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, filters 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.
Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during the procedure. Possible procedure complications include, but are not limited to, the following:
- Air embolism
- Hematoma at the puncture site
- Incorrect positioning of the filter
- Perforation of the vessel wall
- Restriction of blood flow
- Occlusion of small vessel
- Distal embolization
- Intimal tear
- Filter fracture
- Thrombus formation