📊 Evidence-Based Reference
Medtronic Models 4012 4512
Medtronic Vascular
Summary: Medtronic models 4012 and 4512 are IVC filters designed to prevent pulmonary embolism. Cleared by FDA via 510k pathway. Evidence includes 10 studies with varied focus.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K832099 ↗
Decision Date ?
July 26, 1983
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic models 4012 and 4512 were cleared by the FDA through the 510k pathway on July 26, 1983. Manufactured by Medtronic Vascular, these devices are classified as Class 3 under product code DTB.
What It Is
The Medtronic models 4012 and 4512 are inferior vena cava (IVC) filters used to prevent pulmonary embolism by capturing blood clots. They are intended for use in patients at risk of thromboembolic events.
FDA-Cleared Indications
- Prevention of pulmonary embolism in patients at risk for thromboembolic events.
- Mechanical interruption of clot passage through the inferior vena cava.
- Use when anticoagulation therapy is contraindicated or cannot be administered.
- Use when thromboembolic events recur despite anticoagulation therapy.
Clinical Applications
- Placement in the inferior vena cava to prevent venous clots from traveling to the lungs.
- Pulmonary embolism prevention in patients who cannot receive anticoagulant medication.
- Pulmonary embolism prevention when anticoagulation has not adequately prevented recurrent thromboembolism.
- Use during an IVC filter placement procedure performed with imaging guidance.
Reported off-label uses
- Temporary protection from pulmonary embolism during selected high-risk periods when anticoagulation is interrupted.
- Prevention of embolization from upper-extremity or atypical venous thrombosis when an IVC filter is not the usual anatomic solution.
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 10 studies, encompassing various study types such as RCTs and modeling studies, published between 2022 and 2025. These studies explore diverse applications of AI in medical procedures.
Reported Outcomes
Published studies report advancements in AI applications for medical procedures, including improved detection of colorectal polyps and enhanced surgical skill assessments. However, specific outcomes related to Medtronic models 4012 and 4512 are not detailed in the provided evidence.
Safety Profile
Reported complications include the general risks associated with IVC filters, such as filter migration and perforation. However, specific safety data for Medtronic models 4012 and 4512 are not detailed in the provided evidence.
Evidence Limitations
The evidence provided does not directly address the efficacy or safety of Medtronic models 4012 and 4512. Further research is needed to evaluate specific outcomes and complications associated with these devices.
Practical Considerations
- The record identifies models 4012 and 4512 but does not provide their dimensions, delivery-system specifications, or vessel-size range; confirm the original labeling before use.
- Placement requires imaging guidance, typically through venous access in the neck or groin, with positioning in the inferior vena cava below the renal veins when clinically appropriate.
- Review contraindications such as an unsuitable IVC size or anatomy, IVC thrombosis at the intended deployment site, active infection, or inability to safely obtain venous access.
- The available record does not establish MRI compatibility. Confirm MR labeling and conditions for the specific model before MRI.
- An IVC filter does not treat the underlying clot or replace anticoagulation when anticoagulation is safe and indicated. Assess for follow-up and removal when the device is intended to be retrievable; the available record does not establish whether these models are permanent or retrievable.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Medtronic models 4012 and 4512?
The clinical indications include prevention of pulmonary embolism in patients at risk of thromboembolic events, particularly when anticoagulation is contraindicated.
What outcomes have been reported in clinical studies?
The provided studies focus on AI applications in medical procedures, with no specific outcomes reported for Medtronic models 4012 and 4512.
What complications have been reported?
Reported complications include general risks of IVC filters, such as migration and perforation, though specific data for these models are not detailed.
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.