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gunther tulip vena cava filter retrieval set
Cook
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 510K
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.
Clinical Applications
This device is commonly used in scenarios where a vena cava filter needs to be removed, such as after the risk of pulmonary embolism has subsided or if the filter has migrated. It is particularly relevant in cases where the filter has become entangled with thrombus or has migrated to an unintended location.
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.
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.