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Gunther Tulip Vena Cava Filter Retrieval Set
Summary: The Gunther Tulip Vena Cava Filter Retrieval Set is designed for the retrieval of vena cava filters. It is primarily used in patients where filter removal is indicated. Key evidence highlights challenges in retrieval due to filter migration and thrombus entanglement.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K222254 ↗
Decision Date ?
May 16, 2023
Product Code ?
MMX
Device Class ?
Class 2
Evidence ?
10 studies
The Gunther Tulip Vena Cava Filter Retrieval Set was cleared via the FDA 510(k) pathway on May 16, 2023. It is manufactured by Cook and classified as a Class 2 medical device.
What It Is
The Gunther Tulip Vena Cava Filter Retrieval Set is a medical device used to retrieve previously implanted vena cava filters. It is designed to facilitate the safe removal of filters from the inferior vena cava, particularly when the filter is no longer needed or poses a risk to the patient.
FDA-Cleared Indications
- Retrieval of compatible Gunther Tulip vena cava filters from the inferior vena cava.
- Use in patients for whom removal of the implanted vena cava filter is clinically indicated.
Clinical Applications
- Percutaneous retrieval of a Gunther Tulip inferior vena cava filter.
- Removal of a filter after the temporary risk of pulmonary embolism has decreased, when retrieval is clinically appropriate.
- Filter retrieval under fluoroscopic imaging through venous catheter access.
Reported off-label uses
- Advanced or technically difficult retrieval techniques for embedded, tilted, or chronically implanted vena cava filters may be used in selected cases, but these applications may fall outside the device labeling.
- Use of advanced endovascular tools to assist difficult filter retrieval has been described in clinical practice, but should be evaluated case by case by an experienced specialist.
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 11 studies, comprising various study types such as case series and retrospective analyses, conducted between 2011 and 2020. These studies explore the efficacy and safety of the Gunther Tulip Vena Cava Filter Retrieval Set.
Reported Outcomes
Published studies report that the Gunther Tulip Vena Cava Filter Retrieval Set is effective in retrieving filters, although challenges such as filter migration and entanglement with thrombus can occur. Successful retrievals have been documented even in complex cases involving wall-embedded hooks.
Safety Profile
Reported complications include filter migration into the right atrium and perforation of the vena caval wall during retrieval attempts. These events highlight the potential risks associated with long-term filter implantation and retrieval.
Evidence Limitations
The evidence is limited by the retrospective nature of many studies and the small sample sizes. Further research is needed to better understand the long-term outcomes and safety profile of the device, particularly in diverse patient populations.
Practical Considerations
- The set is intended for compatible vena cava filters; the filter type, access route, position, tilt, embedment, fracture, and thrombus should be assessed before retrieval.
- Retrieval is commonly performed through venous access, often through the internal jugular or femoral vein, using fluoroscopic imaging and contrast venography when appropriate.
- Significant thrombus within or around the filter, filter penetration, migration, fracture, or firm tissue ingrowth can make retrieval more difficult or contraindicated until the condition is evaluated.
- Device dimensions and working length must be matched to the patient's anatomy, the filter location, and the planned access route according to the manufacturer's instructions for use.
- MRI safety and conditions depend on the implanted filter and any retained components, not solely on the retrieval set. The specific filter's labeling should be checked before MRI.
Procedures that use this device
Linked Studies (10)
PubMed • 2022
Case report: Endoluminal removal of a retrievable conical inferior vena cava filter with a ruptured retraction hook attached to the wall.
Frontiers in surgery
Case Report View Source →PubMed • 2016
Factors affecting Cook Gunther Tulip and Cook Celect inferior vena cava filter retrieval success.
Journal of vascular surgery. Venous and lymphatic disorders
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2014
Safety and efficacy of the Gunther Tulip retrievable vena cava filter: midterm outcomes.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Successful removal of a Gunther tulip vena cava filter with wall-embedded hook and migration during a retrieval attempt.
Acta radiologica short reports
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2013
Retrieval of gunther tulip vena cava filter with thrombosed hook and a leg incorporated into the vena cava wall.
Annals of vascular diseases
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2011
Endovascular repair of a perforation of the vena caval wall caused by the retrieval of a Gunther Tulip filter after long-term implantation.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2008
Form and function of vena cava filters: how do optional filters measure up?
Vascular
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2007
Evaluation of retrievability of the Gunther tulip vena cava filter.
Cardiovascular and interventional radiology
RCT|prospective|retrospective|case Series|other View Source →PubMed • 2005
New optional IVC filter for percutaneous retrieval--in vitro evaluation of embolus capturing efficiency.
RoFo : Fortschritte auf dem Gebiete der Rontgenstrahlen und der Nuklearmedizin
RCT|prospective|retrospective|case Series|other View Source →ClinicalTrials.gov
Post-Market Celect Platinum Vena Cava Filter and Gunther Tulip Retrieval Set Study
View Source →Frequently Asked Questions
What are the clinical indications for Gunther Tulip Vena Cava Filter Retrieval Set?
The device is indicated for the retrieval of vena cava filters when they are no longer needed or pose a risk, such as migration or thrombus entanglement.
What outcomes have been reported in clinical studies?
Studies report successful retrieval of filters, though challenges such as migration and thrombus entanglement can complicate the process.
What complications have been reported?
Safety data indicate complications such as filter migration into the right atrium and vena caval wall perforation during retrieval.
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.