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Medtronic Model 6972
Medtronic Vascular
Summary: The Medtronic Model 6972 is an IVC filter used to prevent pulmonary embolism. It is FDA 510k cleared and linked to studies reporting on its safety and efficacy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K790462 ↗
Decision Date ?
April 16, 1979
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic Model 6972 was cleared through the FDA 510k pathway on April 16, 1979. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Model 6972 is an inferior vena cava (IVC) filter designed to prevent pulmonary embolism by capturing blood clots. It is intended for use in patients at risk of thromboembolic events.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic disease.
- Use when anticoagulation is contraindicated or cannot be used.
Clinical Applications
- Placement in the inferior vena cava to provide a mechanical barrier to embolizing venous thrombi.
- Pulmonary embolism prevention in selected patients who cannot receive anticoagulant medication.
- Use during management of patients at risk for venous thromboembolism, as determined by the treating physician.
Reported off-label uses
- Prevention of recurrent pulmonary embolism despite adequate anticoagulation.
- Temporary protection from pulmonary embolism during selected high-risk surgical or trauma situations.
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 available literature includes 7 studies, encompassing various study types such as retrospective and prospective analyses. The studies range from 1991 to 2025, providing insights into the device's performance over time.
Reported Outcomes
Published studies report varying outcomes for the Medtronic Model 6972. One study noted a complication rate of 26.3% for this model, indicating a need for careful patient selection and monitoring. Long-term performance data suggest differences in failure rates based on insulation type.
Safety Profile
Reported complications include a 26.3% complication rate for the Medtronic Model 6972, as noted in a study comparing different lead models. Safety profiles vary, highlighting the importance of considering individual patient factors.
Evidence Limitations
The evidence is limited by the variability in study designs and the age of some studies, which may not reflect current clinical practices. Further research is needed to evaluate long-term outcomes and safety in diverse patient populations.
Practical Considerations
- The device is intended for placement in the inferior vena cava; venography or other imaging is used to assess anatomy and guide deployment.
- Patient selection requires assessment of the indication for filtration, bleeding risk, venous anatomy and the ability to use anticoagulation.
- The Model 6972 is an older filter, so current compatibility with delivery systems, imaging equipment and retrieval techniques should be confirmed from the original labeling and institutional records.
- MRI safety status should not be assumed from the 510(k) record alone. Confirm the device's MR labeling and conditions with the manufacturer or applicable device documentation.
- An IVC filter does not treat the underlying clot. Filter thrombosis, migration, embolization, perforation and recurrent deep vein thrombosis or pulmonary embolism are potential complications.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Medtronic Model 6972?
The device is indicated for use in patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Studies report a complication rate of 26.3% and highlight differences in performance based on lead insulation type.
What complications have been reported?
Safety data indicate a 26.3% complication rate, with variations based on specific device models and patient factors.
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.