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Alligator Retrieval Device Ard
Chestnut Medical Technologies
Summary: The Alligator Retrieval Device (ARD) is used in endovascular procedures to retrieve or reposition devices within blood vessels. It is primarily used by interventional radiologists and neurosurgeons.
FDA Clearance Information
Pathway ?
510(k)
Number ?
K043580 ↗
Decision Date ?
March 24, 2005
Product Code ?
DQY Catheter, Percutaneous
Device Class ?
Class 2
Evidence ?
0 studies
The Alligator Retrieval Device ARD was cleared via the FDA 510(k) pathway on March 24, 2005. It is manufactured by Chestnut Medical Technologies and is classified as a Class 2 device under product code DQY.
What It Is
The Alligator Retrieval Device is a specialized tool designed for retrieving or repositioning devices within the vascular system. It features a flexible, maneuverable design that allows clinicians to navigate through blood vessels to capture and remove foreign objects or misplaced stents. This device is particularly useful in complex endovascular procedures where precision and control are crucial.
FDA-Cleared Indications
- Retrieval of misplaced or displaced endovascular devices from blood vessels.
- Repositioning of endovascular devices within the vascular system.
- Use as a percutaneous catheter device during endovascular intervention.
Clinical Applications
- Retrieving a displaced or misplaced stent during an endovascular procedure.
- Repositioning a stent or other endovascular device within a blood vessel.
- Removing an intravascular device or foreign object when percutaneous endovascular retrieval is appropriate.
- Use during complex peripheral or intracranial vascular interventions when an endovascular device has become malpositioned or deformed.
Practical Considerations
- The device is available in configurations intended for different vessel sizes and procedural requirements; the operator must select an appropriate size.
- It is used through compatible endovascular access equipment under fluoroscopic or other intravascular imaging guidance.
- Careful manipulation is required to reduce the risk of vessel injury, dissection, perforation, thrombosis, or embolization.
- The FDA record and supplied information do not establish that the device is MRI safe; MRI compatibility should be verified from the current device labeling before scanning.
- Contraindications, access requirements, anticoagulation, and retrieval technique should be determined from the current instructions for use and the patient's anatomy and clinical condition.
Related Literature
The linked study discusses the use of the Alligator Retrieval Device in two cases where intracranial stents were inadvertently deformed and displaced. The ARD was successfully used to reposition the stents, preventing potential complications such as thromboembolic events. The study highlights the device's utility in complex endovascular procedures but is limited by its small sample size and focus on specific cases.
Procedures that use this device
Frequently Asked Questions
What is the Alligator Retrieval Device ARD used for?
The ARD is used to retrieve or reposition devices, such as stents, within the vascular system, particularly when they have been displaced or deformed.
What specialties typically use this device?
Interventional radiologists and neurosurgeons commonly use the ARD in endovascular procedures.
What are the FDA-cleared indications?
The ARD is indicated for retrieving or repositioning devices within the vascular system, especially in cases of displaced or deformed stents.
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.