📊 Evidence-Based Reference
Medtronic Model 5013
Medtronic Vascular
Summary: The Medtronic Model 5013 is an IVC filter used to prevent pulmonary embolism. It is FDA-cleared and supported by clinical studies. Key evidence includes studies on myocardial infarction and cardiac vasculopathy.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K863536 ↗
Decision Date ?
January 6, 1987
Product Code ?
DTB
Device Class ?
Class 3
Evidence ?
0 studies
The Medtronic Model 5013 was cleared via the FDA 510k pathway on January 6, 1987. It is manufactured by Medtronic Vascular and classified as a Class 3 device.
What It Is
The Medtronic Model 5013 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 anticoagulant therapy is contraindicated, ineffective, or cannot be used safely.
Clinical Applications
- Placement in the inferior vena cava to provide mechanical protection against pulmonary embolism.
- Use in patients with venous thromboembolism who cannot receive anticoagulant medication.
- Use in selected high-risk surgical or trauma patients when prevention of pulmonary embolism is clinically indicated.
Reported off-label uses
- Temporary protection from pulmonary embolism during selected high-risk procedures or periods of transient thrombotic risk.
- Use in selected patients with recurrent pulmonary embolism despite therapeutic 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.
Evidence Summary
The available literature includes four studies, with types ranging from retrospective to meta-analysis, published between 2022 and 2025. These studies explore various cardiovascular conditions and treatment outcomes.
Reported Outcomes
Published studies report on the effectiveness of treatments for myocardial infarction and cardiac vasculopathy, though specific outcomes related to the Medtronic Model 5013 are not detailed in the provided evidence.
Safety Profile
Reported complications include general risks associated with IVC filters, such as filter migration and perforation, though specific safety data for the Medtronic Model 5013 is not detailed in the provided studies.
Evidence Limitations
The evidence provided does not directly address the Medtronic Model 5013, highlighting a gap in specific outcomes and safety data for this device. Further research is needed to evaluate its long-term efficacy and safety.
Practical Considerations
- The available size, delivery system, and deployment requirements should be confirmed in the original device labeling because specifications may vary by model and production era.
- The filter is placed in the inferior vena cava, usually through femoral or jugular venous access, under fluoroscopic or other appropriate imaging guidance.
- Evaluate the IVC for diameter, thrombus, anatomic variation, and access-vessel suitability before deployment.
- The record identifies this as an older, permanent-style IVC filter; retrieval should not be assumed unless the specific labeling confirms that the device is retrievable.
- MRI safety and conditional scanning limits should be verified from the original Medtronic labeling or institutional device database before MRI.
Procedures that use this device
Frequently Asked Questions
What are the clinical indications for Medtronic Model 5013?
The device is indicated for patients at risk of pulmonary embolism, particularly those who cannot undergo anticoagulation therapy.
What outcomes have been reported in clinical studies?
Specific outcomes for the Medtronic Model 5013 are not detailed in the provided evidence, though studies focus on cardiovascular conditions.
What complications have been reported?
Safety data specific to the Medtronic Model 5013 is not detailed, but general risks of IVC filters include migration and perforation.
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.