INTENDED USE

The Gianturco-Roehm Bird's Nest Vena cava filter is intended for the prevention of recurrent pulmonary embolism via placement in the vena cava in the following situations:

1. Pulmonary thromboembolism when anticoagulants are contraindicated
2. Failure of anticoagulant therapy in thromboembolic disease;
3. Emergency treatment following massive pulmonary embolism where anticipated benefits of conventional therapy are reduced
4. Prophylactically in patients with cronic , recurrent pulmonary embolism where anticoagulant therpay has failed or is contraindicated

CONTRAINDICATIONS

• Vena cava filters should not be implanted in patients with risk of septic embolism
• The Bird's Nest filter should not be used in patients with a vena cava larger than 40 mm diameter

WARNINGS

• if severe resistance is met when advancing the wire guide, then retract the wire guide and choose a different approach
• Do not rotate the expanded filter hooks inside the vena cava. Doing so may compromise the performance of the filter.
• Excessive force should not be exerted during placement of the filter.
• Be certain the junction point of the distal pair of hooks is in the catheter tip when positioning these hooks into the caval wall. If there is uncertainty regarding hook fixation, the catheter may be advanced up over the hook wires to the edge of the hooks. The catheter may then be repositioned and the filter placement re-initiated in a slightly different caval orientation or level.
• No technique will completely eliminate the possibility of recurrent PE.

POTENTIAL ADVERSE EVENTS

• Access site thrombosis/occlusion
• Air embolism
• Arrhythmia
• Back or abdominal pain
• Branch vessel occlusion
• Cardiac damage
• Cardiac tamponade
• coagulopathy
• Damage to the vena cava
• Death
• Deep vein thrombosis
• Extravasation of contrast material
• Failure to adequately deploy
• Filter fracture
• Filter migration
• Filter or filter fragment embolization
• Filter malpositoning
• Hemorrhage
• Hematoma at vascular access site
• Infection at vascular access site
• Intimal tear
• Obstruction of blood flow
• Pneumothrox
• Postphlebitic syndrome
• Pulmonary embolism
• Trauma to adjacent structures
• Vascular trauma
• Vena cava perforation
• Vena cava penetration
• Vena cava occlusion or thrombosis
• Vena cava stenosis