Stainless Steel Greenfield Vena Cava Filter with 12f Introducer System

FDA-Cleared Indications

• Prevention of pulmonary embolism by trapping emboli in the inferior vena cava.
• Use in patients at risk for pulmonary embolism who have contraindications to anticoagulant therapy.

Clinical Applications

• Placement in the inferior vena cava for pulmonary embolism protection when anticoagulation cannot be used.
• Use in selected patients with venous thromboembolism who cannot receive anticoagulant therapy.
• Percutaneous IVC filter placement using the supplied 12 French introducer system.

Reported off-label uses

• Use when anticoagulation is considered ineffective or poorly tolerated, depending on the patient's clinical circumstances.
• Prophylactic placement in selected patients considered at unusually high risk for pulmonary embolism but without documented venous thromboembolism.

Off-label use: these uses are reported in practice or the literature but are not part of the FDA-cleared indications. Physicians may use a cleared device off-label based on their medical judgment; the manufacturer may not promote off-label uses.

Practical Considerations

• The device is delivered through a 12 French introducer system; access is commonly obtained through the jugular or femoral vein under fluoroscopic guidance.
• The stainless steel filter is a permanent filter design and is not generally treated as a routine retrievable filter; removal may be difficult or require advanced techniques.
• Deployment requires accurate positioning in the inferior vena cava and assessment of venous anatomy, including renal vein location and caval diameter.
• Potential complications include filter tilt, migration, fracture, perforation, caval thrombosis, access-site bleeding, and recurrent or new venous thromboembolism.
• MRI safety and conditions should be confirmed from the device-specific labeling and institutional MRI policy before scanning; the implant's stainless steel composition does not by itself establish unrestricted MRI safety.