📊 Evidence-Based Reference
Vena Cava Filter
Summary: The vena cava filter by Cook is a device used to prevent thromboembolism in high-risk patients. Key evidence highlights complications associated with retrieval and long-term use.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K073528 ↗
Decision Date ?
February 27, 2008
Product Code ?
DTK Filter, Intravascular, Cardiovascular
Device Class ?
Class 2
Evidence ?
0 studies
The Cook vena cava filter was cleared by the FDA through the 510(k) pathway on February 27, 2008. It is classified as a Class 2 medical device.
What It Is
The vena cava filter is a medical device designed to prevent pulmonary embolism by capturing blood clots in the inferior vena cava. It is primarily used in patients who cannot undergo anticoagulation therapy.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients with documented venous thromboembolism who have a contraindication to anticoagulation.
- Prevention of pulmonary embolism in patients with documented venous thromboembolism when anticoagulation has failed or is not effective.
- Prevention of pulmonary embolism in selected patients at high risk for venous thromboembolism when anticoagulation is contraindicated.
Clinical Applications
- Placement in the inferior vena cava for patients with deep vein thrombosis who cannot safely receive anticoagulants.
- Placement for patients with pulmonary embolism or venous thromboembolism despite appropriate anticoagulation.
- Temporary protection from pulmonary embolism when anticoagulation must be stopped because of bleeding, surgery, or another contraindication.
- Use during image-guided IVC filter placement by interventional radiology or vascular specialists.
Reported off-label uses
- Prophylactic placement in selected trauma patients or critically ill patients without documented venous thromboembolism.
- Prophylactic placement in selected patients undergoing major surgery when anticoagulation is temporarily contraindicated.
- Use in selected patients with cancer-associated thrombosis when anticoagulation is not possible or has failed.
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.
Evidence Summary
The literature includes a mix of systematic reviews, case series, and narrative reviews, with a total of 15 studies published up to 2024. These studies explore retrieval complications, long-term outcomes, and appropriateness of use.
Reported Outcomes
Published studies report that vena cava filters are effective in preventing thromboembolism in patients with contraindications to anticoagulation. However, retrieval rates are low, and long-term complications such as filter thrombosis and vena cava erosion have been noted.
Safety Profile
Reported complications include increased risk of mechanical issues such as embedded or tilted filters, erosion of the vena cava, and filter thrombosis. These complications can lead to venous hypertension and post-thrombotic syndrome.
Evidence Limitations
Evidence gaps include a need for more prospective studies on long-term outcomes and retrieval techniques. Current studies often have small sample sizes and lack uniformity in reporting complications.
Practical Considerations
- The specific filter model determines whether it is permanent, retrievable, or indicated for both intended uses; the product labeling should be reviewed before placement.
- Filter size and delivery-system compatibility depend on the inferior vena cava diameter and the access system specified for the model. Pre-procedure imaging is typically used to assess anatomy, thrombus, and vessel size.
- Placement is commonly performed through femoral or internal jugular venous access under fluoroscopic imaging, usually with local anesthesia and optional moderate sedation.
- MRI compatibility is model-specific. Confirm the exact Cook filter model and its MR-conditional labeling before MRI; the FDA clearance record alone does not establish unrestricted MRI safety.
- Potential complications include access-site bleeding, filter migration, tilt, fracture, IVC perforation, thrombosis, and pulmonary embolism. Retrievable filters should be evaluated for removal when protection is no longer needed because retrieval can become more difficult over time.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for vena cava filter?
Indicated for patients at risk of thromboembolism who cannot undergo anticoagulation therapy, such as those with deep venous thrombosis or cancer-associated thrombosis.
What outcomes have been reported in clinical studies?
Studies report effective prevention of thromboembolism but highlight low retrieval rates and long-term complications.
What complications have been reported?
Complications include embedded or tilted filters, erosion of the vena cava, and filter thrombosis, leading to potential venous hypertension and post-thrombotic syndrome.
Disclaimer: This page compiles publicly available regulatory and published clinical evidence for educational reference.
It does not constitute medical advice, product endorsement, or a recommendation for clinical use.
Always consult manufacturer documentation and clinical judgment for patient care decisions.