February 28, 2017
FDA Letter Warns About Off-Label Use of Neurovascular Guide Catheters for Thrombus Removal
March 1, 2017—The Center for Devices and Radiological Health (CDRH) of the US Food and Drug Administration (FDA) issued a letter to health care providers regarding the differences in the FDA review and the intended use of neurovascular thrombus retrieval catheters and guide catheters (eg, intermediate catheters, distal access catheters) for neurological interventional procedures.
In the letter, CDRH Deputy Center Director for Science William Maisel, MD, advised that the FDA has received a small number of adverse event reports associated with the use of neurovascular guide catheters for removal of thrombus, including a report associated with vessel perforation and death from a subsequent large subarachnoid hemorrhage.
Additionally, the agency is aware of marketing materials and recently published literature that imply a new intended use for some neurovascular guide catheters for neurovascular thrombus removal in patients with acute ischemic stroke; however, the FDA has not cleared neurovascular guide catheters for this use.
According to the CDRH letter, use of neurovascular guide catheters for thrombus removal may affect the safety and performance of the device, 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.
The letter stressed that the premarket review and cleared indications for use for each of the neurovascular thrombus retrieval catheters versus guide catheters are significantly different. Additionally, the devices may have possible differences in device design. Different design features may include length, diameter, and variations in material stiffness distally and proximally. The letter is intended to highlight these differences to help mitigate risks to patients.
The clinical complications of using neurovascular guide catheters for removal of thrombus may be attributed by the clinician to the disease state rather than to the use of these devices for thrombus removal, which could make recognition of device-related adverse events more difficult.
Information on which devices have been cleared as neurovascular thrombus retrieval catheters (FDA product code: NRY) and neurovascular guide catheters (FDA product code: DQY) can be accessed using the FDA's 510(k) Premarket Notification Database. Health care professionals can contact the device manufacturer or refer to the cleared indications for use in the device labeling. The FDA's Division of Industry and Consumer Education can be contacted at DICE@fda.hhs.gov, (800) 638-2041, or (301) 796-1000.