Greenfield Vena Cava Filter W 19 5 Fr Introducer

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients with deep vein thrombosis who cannot receive anticoagulant therapy.
• Prevention of recurrent pulmonary embolism in patients whose embolism has occurred despite anticoagulant therapy.

Clinical Applications

• Placement in the inferior vena cava for pulmonary embolism prevention.
• Treatment of patients with deep vein thrombosis who have a contraindication to anticoagulation.
• Treatment of recurrent embolism despite anticoagulant therapy.
• Placement by catheter through a venous access site, such as the groin or neck.

Reported off-label uses

• Temporary pulmonary embolism protection when anticoagulation must be interrupted for selected high-risk surgery or trauma care.
• Pulmonary embolism protection in selected patients considered at exceptionally high risk despite an ability to receive anticoagulation.

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 record identifies compatibility with a 19.5 French introducer, which requires a relatively large venous access sheath compared with many newer IVC filters.
• Placement requires imaging guidance and assessment of IVC anatomy, clot burden, and the intended deployment location.
• This device is a permanent Greenfield filter unless a specific model and labeling establish retrievability; the treating physician should confirm the exact model before planning removal.
• MRI conditions should be confirmed from the device-specific labeling and implant records before an MRI examination. Do not assume MRI safety from the product name alone.
• Potential complications include access-site bleeding, malposition, IVC or venous injury, filter migration or fracture, caval thrombosis, and recurrent or trapped emboli.