Posted 01 March 2017
By Michael Mezher
The US Food and Drug Administration (FDA) on Wednesday warned healthcare providers of potential harm to patients when neurovascular guide catheters are used to remove blood clots in stroke patients.
"FDA was originally made aware of the issue based on information received from a complaint alleging regulatory misconduct, which made the agency aware that marketing materials from multiple companies imply a new intended use for some neurovascular guide catheters for neurovascular thrombus removal in patients with acute ischemic stroke," FDA spokesperson Stephanie Caccomo told Focus.
FDA says it has received a small number of adverse event reports indicating patient injury, and at least one death, associated with neurovascular guide catheters used in this manner.
Specifically, FDA says it wants to clarify that despite similarities between the two devices, neurovascular thrombus retrieval catheters and neurovascular guide catheters are approved for different indications and may have design differences that could lead to complications when used interchangeably.
While neurovascular thrombus retrieval catheters (FDA product code NRY) are typically cleared for restoring blood flow or removing blood clots within the brain, neurovascular guide catheters (FDA product code DQY) are cleared for introducing other interventional devices into the neurovasculature, or as a conduit for clot retrieval devices.
"Neurovascular guide catheters and thrombus retrieval catheters may be designed with different features (e.g., length, diameter, variations in material stiffness distally and proximally). Use of neurovascular guide catheters for thrombus removal may affect the safety and performance, which could result in device failure and/or serious adverse events such as vessel damage, perforation, or dissection when used in the most distal regions of the neurovasculature," FDA writes.
The agency also warns that adverse events tied to neurovascular guide catheters used for thrombus removal may be difficult to recognize, as clinicians may attribute the adverse event to the patient's disease state rather than to the use of the device.
As a result, FDA cautions healthcare providers to refer to the FDA cleared labeling for such devices when making decisions about their use.