Key Product Attributes

• Coil-reinforced outer sheath for strength to detach filter legs from the IVC wall
• 15° curve at the distal tip of the snare catheter allows for directional control
• Radiopaque bands on the snare catheter, inner sheath, and outer sheath increase visibility for control when capturing and sheathing over the IVC filter. Embedded radiopaque marker increases visibility for sheathing over filter legs.
• Three independent loops for complete vessel coverage (Triple-Loop)
• Platinum strands (Triple-Loop) or gold-plated tungsten loop (Single-Loop) for visibility when snaring retrieval hook
• Nitinol wire allows for 1:1 torque control and kink resistance
• Holes around the distal tip of the dilator for even distribution of contrast during power injection

Contraindications for Use

None known

Warnings

 Do not use the device or accessories after the expiration date.

 Contents are supplied sterile and are intended for single use only. Do not re-sterilize. Do not use if sterile barrier is damaged.

 Do not continue to use any component damaged during the procedure.

 Do not use excessive force when advancing, retracting, or manipulating kit components and accessories.

 Do not overtighten hub connections.

 Risks and benefits should be carefully assessed in pregnant patients as radiation from fluoroscopic imaging may endanger the fetus.

 Use fluoroscopic guidance when advancing, retracting, or manipulating kit components and accessories in the vasculature.

 Do not remove an IVC filter from patients with heightened risk of pulmonary embolism (PE).

 Do not attempt removal if collapsing the IVC filter will cause thrombus contained within the basket to embolize.

 Do not redeploy a removed IVC filter.

 The side port extension tube of this product contains Di(2- ethlhexyl) phthalate (DEHP) which has been shown to cause reproductive harm in male neonates, pregnant women carrying male fetuses, and peripubertal males. The following procedures have been identified as posing the greatest risk for DEHP exposure: exchange transfusion in neonates, total parenteral nutrition (TPN) in neonates (with lipids in polyvinylchloride (PVC) bag), multiple procedures in sick neonates (high cumulative exposure), heart transplantation or coronary artery bypass graft surgery (aggregate dose), and massive infusion of blood into trauma patient. It is recommended that DEHP-free medical products be considered when these procedures are to be performed on male neonates, pregnant women who are carrying male fetuses, and peripubertal males.  

Precautions

 For use by physicians trained in vascular diagnostic and interventional techniques only.

 Vascular access is necessary to allow retrieval of IVC filters.

 A patient may experience a negative reaction to angiography if the patient is allergic to contrast medium or has compromised renal function.

 Anatomical variances, including spinal deformations, may complicate the removal procedure.

 Avoid entangling a guidewire, sheath or catheter in an IVC filter.

 Consider removing a guidewire entrapped in an IVC filter prior to attempting IVC filter retrieval. An entrapped guidewire may prevent the IVC filter from collapsing sufficiently to fit within the inner or outer sheath.  Avoid engaging the arms or legs of an IVC filter when using a snare to engage the IVC filter hook.

 If resistance is experienced during removal of a IVC filter, check the captured IVC filter and the retrieval sheath using fluoroscopy.

 It may not be possible to snare a IVC filter hook if it is embedded in the vessel wall.

 Follow all contraindications, warnings, cautions, precautions and instructions for all infusates, including contrast medium as specified by their manufacturer. 

Procedures requiring percutaneous interventional techniques should not be attempted by physicians unfamiliar with the potential complications. These events may be serious in nature and may require hospitalization or intervention to address the condition.

Possible complications of Single-Loop Snare Retrieval Kit and Triple-Loop Snare Retrieval Kit usage include, but are not limited to the following:

 Thrombosis

 Pulmonary embolism

 Hematoma

 Perforation of vessels

 Infection

 Hemorrhage

 Cardiac arrhythmia

 Damage to the artery or vein

 Guidewire entrapment

 Caval thrombosis/occlusion

 Insertion site thrombosis

 Extravasation of contrast material at time of imaging

 Hematoma or nerve injury at the puncture site

 Restriction of blood flow

 Stenosis at implant site

 Stroke

 Blood loss

 Pain

 Death

NOTE:

It is possible that complications such as those described in the “Warnings”, “Precautions”, or “Potential Complications” sections of this Instructions For Use will affect the recoverability of the device and result in the clinician’s decision to have the filter remain permanently implanted.