Denali™ Vena Cava Filter

Safety and Risk Information

Indication 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 in the Instructions for Use under the 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 28 mm
• 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 Jugular/Subclavian System is designed for Jugular/Subclavian approaches only. Never use the Denali™ Filter Jugular/Subclavian System for femoral approaches, as this will result in improper filter orientation within the IVC. 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 willresult in improper filter orientation within the IVC.9) If the Vena Cava diameter is greater than 28 mm 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 the Instructions for Use may affect the recoverability of the device and result in the clinician’s decision to have the device remain permanently implanted.

Precautions 

1) This product is intended for use by physicians trained and experienced in diagnostic and interventional techniques. 2) The safety and effectiveness of this device has not been established for pregnancy, nor in suprarenal placement position. 3) The safety and effectiveness of this device has not been established for pediatric patients. 4) The safety and effectiveness of this device has not been established for morbidly obese patients. Abdominal procedures such as bariatric surgery may affect the integrity and stability of the filter. 5) Anatomical variances may complicate filter insertion, deployment and removal. Careful attention to these Instructions for Use can shorten insertion time and reduce the likelihood of difficulties. 6) Procedures or activities that lead to changes in intra-abdominal pressure could affect the integrity or stability of the filter. 7) Position the filter snare hook 1cm below the lowest renal vein. Venacavography must always be performed to confirm proper implant site. Radiographs without contrast, which do not clearly show the wall of the IVC, may be misleading. 8) When measuring caval dimensions, consider an angiographic catheter or IntraVascular Ultrasound (IVUS) if there is any question about caval morphology. 9) If misplacement, sub-optimal placement, or tilting of the filter occurs, consider immediate removal. Do not attempt to reposition the filter. 10) Spinal deformations: It is important to exercise care when contemplating implantation or removal in patients with significant kyphoscoliotic spinal deformations because the IVC may follow the general course of such anatomic deformations. This may require advanced interventional techniques to remove the filter. 11) In patients with continued risk of chronic, recurrent pulmonary embolism, patients should be returned to antithrombotic therapy as soon as it is deemed safe. 12) If resistance is encountered during a jugular/subclavian or femoral insertion procedure, withdraw the guidewire and check vein patency fluoroscopically with a small injection of contrast medium. If a large thrombus is present, remove the venipuncture needle and use the vein on the opposite side. A small thrombus may be bypassed by the guidewire and introducer. 13) It is very important to maintain introducer patency with a saline flush to prevent occlusion of the introducer, which may interfere with delivery device advancement. 14) The introducer sheath has a radiopaque distal marker band to assist in visualization and pre-deployment filter positioning for proper filter placement. 15) Do not attempt to attach a syringe or power injection line to the proximal end of the introducer sheath hub. 16) Care should be taken to ensure the connection between the introducer sheath hub and the filter storage tube is tight; however, the use of excessive force which can cause slippage of the threads and/or breakage of the hub should be avoided. 17) Do not deliver the filter by pushing it beyond the end of the introducer sheath. To achieve proper placement, unsheath the stationary filter by withdrawing the introducer sheath. Do not twist the pusher handle at anytime during this procedure. 18) Aspirating the introducer sheath while leaving the guidewire in place may lead to the introduction of air into the system. 19) If accidentally deployed, do not attempt to reinsert the filter into the filter storage tube as damage to the legs and hooks can occur. 20) For placement of the filter using the Denali™ Filter Jugular/Subclavian System, the right jugular vein is preferable. For placement of the filter using the Denali™ Filter Femoral System, the right femoral vein is preferable. 21) Care should be taken when advancing a guidewire or imaging catheter through a filter to prevent entanglement. 22) The retrieval of the Denali™ Vena Cava Filter should only be performed using minimum 9F I.D./11F I.D. dual retrieval sheaths. Misuse of these devices or improper retrieval technique may result in intimal injury or caval narrowing. 23) Care should be taken when advancing the 9F retrieval sheath in the caudal direction to avoid completely covering the arms and legs.

NOTE: Standards and guidelines developed by the Society of Interventional Radiologists recommend that patients with filters (either permanent or retrievable) be tracked and receive "routine follow-up" subsequent to the placement of the device. FDA recommends that implanting physicians and clinicians responsible for the ongoing care of patients with retrievable IVC filters consider removing the filter as soon as protection from PE is no longer needed. FDA encourages all physicians involved in the treatment and follow-up of IVC filter recipients to consider the risks and benefits of filter removal for each patient.

 See Reporting Standards for Inferior Vena Caval Filter Placement and Patient Follow-up: Supplement for Temporary and Retrievable/Optional Filters. Millward, S., et al.: J. Vasc Interv Radiol 2005; 16:441- 443; Recommended Reporting Standards for Vena Cava Filter Placement and Patient Follow-up. The Participants in the Vena Caval Filter Consensus Conference: J Vasc Inter Radiol 2003; 14:S427-S432; Guidelines for the Use of Retrievable and Convertible Vena Cava Filters: Report from the Society of Interventional Radiology Multidisciplinary Consensus Conference. Kaufman, J., et al.: J Vasc Interv Radiol 2006; 17:449-459.

Potential Complications

Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the possible complications. Complications may occur at any time during or after the procedure. Possible complications include, but are not limited to, the following: • Movement, migration or tilt of the filter 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 of the filter. Migration may be caused by placement 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. • 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. • Detachment of components. • Perforation or other acute or chronic damage of the IVC wall. • Acute or recurrent pulmonary embolism. This has been reported despite filter usage. It is not known if thrombi passed through the filter, or originated from superior or collateral vessels. • Deep vein thrombosis. • Caval thrombosis/occlusion. • Extravasation of contrast material at time of venacavogram. • Air embolism. • Hematoma or nerve injury at the puncture site or subsequent retrieval site. • Hemorrhage. • Restriction of blood flow. • Occlusion of small vessels. • Distal embolization. • Infection. • Intimal tear. • Stenosis at implant site. • Failure of filter expansion/incomplete expansion. • Insertion site thrombosis. • Filter malposition. • Vessel injury. • Arteriovenous fistula. • Back or abdominal pain. • Filter tilt. • Hemothorax. • Organ injury. • Phlegmasia cerulea dolens. • Pneumothorax. • Postphlebitic syndrome. • Stroke. • Thrombophlebitis. • Venous ulceration. • Blood loss. • Guidewire entrapment. • Pain.

All of the above complications may be associated with serious adverse events such as medical intervention and/or death. There have been reports of complications including death, associated with the use of vena cava filters in morbidly obese patients. The risk/benefit ratio of any of these complications should be weighed against the inherent risk/ benefit ratio for a patient who is at risk of pulmonary embolism without intervention.

Please consult package insert for more detailed safety information and instructions for use.

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