Medtronic Model 6971

FDA-Cleared Indications

• Prevention of pulmonary embolism in patients at risk for venous thromboembolism.
• Use in patients who have a contraindication to anticoagulation therapy.

Clinical Applications

• Placement in the inferior vena cava to provide a mechanical barrier to emboli from the lower extremities or pelvis.
• Pulmonary embolism prevention when anticoagulant medication cannot be used.
• Use during image-guided IVC filter placement by an interventional physician.

Reported off-label uses

• Pulmonary embolism prevention in selected patients who can receive anticoagulation but have persistent, unusually high thromboembolic risk.
• Use as an adjunct in selected patients with recurrent pulmonary embolism despite 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

• This is a permanent, nonretrievable IVC filter design; removal should not be assumed unless the specific device labeling and clinical circumstances support it.
• The filter is placed in the inferior vena cava, typically through venous access in the neck or groin, using fluoroscopic imaging.
• The available size range, delivery-system compatibility, and minimum vessel diameter should be confirmed in the original device labeling before use.
• MRI safety and conditions should be verified from the original Medtronic labeling or institutional device database; do not assume that an older filter is MRI safe without confirmation.
• Potential complications include access-site bleeding, filter migration or malposition, IVC perforation, filter or venous thrombosis, and recurrent pulmonary embolism.