The DENALI® Vena Cava Filter was determined to be MR-conditional according to the terminology specified in the American Society for Testing and Materials (ASTM) International, Designation: F2503-05. Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment. ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, Pennsylvania, 2005. Non-clinical testing demonstrated that the DENALI® Vena Cava Filter is MR Conditional.
A patient with this implant can be scanned safely immediately after placement under the following conditions:
• Static magnetic field of 3-Tesla or 1.5-Tesla
• Spatial gradient magnetic field of 720-Gauss/cm or less
• Maximum MR system reported whole-body-averaged specific absorption rate (SAR) of 2-W/kg in the normal operating mode In non-clinical testing, the DENALI® Vena Cava Filter produced a temperature rise of 2.7°C at a maximum MR system-reported whole body averaged specific absorption rate (SAR) of 3-W/kg for 15-minutes of continuous MR scanning in a 3-Tesla MR system using a transmit/receive body coil (Excite, Software G3.0-052B, General Electric Healthcare, Milwaukee, WI). 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 DENALI® Vena Cava Filter. Therefore, optimization of MR imaging parameters to compensate for the presence of this implant may be necessary.
Indications for Use
The DENALI® Filter is indicated for use in the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:
• Pulmonary thromboembolism when anticoagulants are contraindicated
• Failure of anticoagulant therapy for thromboembolic disease
• 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 DENALI® Filter may be removed according to the instructions supplied under section labeled: “Optional Procedure for Filter Removal”.
Contraindications for Use
The DENALI® Vena Cava Filter should not be implanted in:
• Patients with an IVC diameter larger than 28mm.
• Pregnant patients when fluoroscopy may endanger the fetus. Risks and benefits should be assessed carefully.
• Patients with risk of septic embolism.
• Patients with uncontrolled sepsis
• Patients with known hypersensitivity to nickel-titanium alloys. The DENALI® Vena Cava Filter should not be retrieved if significant thrombus is in or near the filter.
Warnings
1. The DENALI® Filter consists of nickel-titanium alloy, which is generally considered safe. However, in vitro testing has demonstrated that nickel is released from this device. Persons with allergic reactions to nickel may suffer an allergic response to this implant, especially those with a history of metal allergies. Some patients may develop an allergy to nickel if this device is implanted. Certain allergic reactions can be serious. While devices that release nickel are not expected to result in symptoms such as difficulty in breathing or inflammation of the face or throat, if these types of allergic reactions occur, patients should be instructed to seek immediate medical attention. Some forms of nickel have also been associated with carcinogenicity (ability to cause cancer) in animal models. It is unknown whether nickel released from implants will increase a patient’s cancer risk.
2. Do not use the device or accessories after the expiration date.
3. Contents are supplied sterile. Do not use if the product sterilization barrier or its packaging is compromised.
4. This device has been designed for single use only. Reusing this medical device bears the risk of cross-patient contamination as medical devices - particularly those with long and small lumina, joints, and/or crevices between components - are difficult or impossible to clean once body fluids or tissues with potential pyrogenic or microbial contamination have had contact with the medical device for an indeterminable period of time. The residue of biological material can promote the contamination of the device with pyrogens or microorganisms which may lead to infectious complications.
5. Do not deploy the filter prior to proper positioning in the IVC, as the DENALI® Vena Cava Filter cannot be safely reloaded into the storage tube. Do not deploy the filter unless IVC has been properly measured. Never re-deploy a removed filter.
6. Do not resterilize. After resterilization, the sterility of the product is not guaranteed because of an indeterminable degree of potential pyrogenic or microbial contamination which may lead to infectious complications. Cleaning, reprocessing, and/or resterilization of the present medical device increases the probability that the device will malfunction due to potential adverse effects on components that are influenced by thermal and/or mechanical changes.
7. Delivery of the DENALI® Filter through the introducer sheath is advance only. Retraction and twisting of the pusher during delivery could result in dislodgement of the filter, crossing of filter legs or arms, and could prevent the filter from further advancement within the introducer sheath.
8. The DENALI® Filter Femoral System is designed for femoral approaches only. Never use the DENALI® Filter Femoral System for superior approaches (jugular, subclavian or antecubital vein), as this will result in improper filter orientation within the IVC.
9. If the Vena Cava diameter is greater than 28mm do not deploy the DENALI® Filter.
10. If large thrombus is demonstrated at the initial delivery site, do not attempt to deliver the filter through it as migration of the clot and/or filter may occur. Attempt filter delivery through an alternate site. A small thrombus may be bypassed by the guidewire and introducer sheath.
11. When injecting contrast medium through the dilator, do not exceed the maximum pressure rating of 800 psi.
12. Never advance the guidewire or introducer sheath/dilator or deploy the filter without fluoroscopic guidance.
13. Filter fractures are a known complication of vena cava filters. There have been some reports of serious pulmonary and cardiac complications with vena cava filters requiring the retrieval of the fragment utilizing endovascular and/or surgical techniques.
14. Movement, migration or tilt are known complications of vena cava filters. Migration of filters to the heart or lungs has been reported. There have also been reports of caudal migration. Migration may be caused by placement of the filter in IVCs with diameters exceeding the appropriate labeled dimensions specified in this IFU. Migration may also be caused by improper deployment, deployment into clots and/or dislodgement due to large clot burdens.
15. After use, the DENALI® Vena Cava Filter System and accessories may be a potential biohazard. Handle and dispose of in accordance with accepted medical practice and applicable local, state and federal laws and regulations.
16. After filter implantation, any catheterization procedure requiring passage of a device through the filter may be impeded, or filter may become entangled.
17. Do not attempt to remove the DENALI® Filter if significant amounts of thrombus are trapped within the filter or if the filter snare hook is embedded within the cava wall.
18. Remove the DENALI® Filter using an intravascular snare only. Refer to the “Optional Procedure for Filter Removal” section for details. Note: Reference “Potential Complications” section for further information regarding other known filter complications. Note: It is possible that complications such as those described in the “Warnings”, “Precautions”, or “Potential Complications” sections of this Instructions for Use may affect the recoverability of the device and result in the clinician’s decision to have the device remain permanently implanted.
