The United States Food and Drug Administration (FDA) has issued a medical device safety alert concerning neurovascular stents used for stent-assisted coiling (SAC).
FDA received reports associated with the use of these devices in the treatment of unruptured brain aneurysms that suggest some events of peri-procedural stroke and/or death may have been related to procedural risks or patient selection related factors. These factors include patients who had serious co-morbidities resulting in a reduced life expectancy, or who were intolerant to required anticoagulation or anti-platelet therapy.
Neurovascular stents used for SAC are intended to treat wide-neck, intracranial, saccular aneurysms, arising from various sized parent vessel diameters depending on the manufacturers' intended use (e.g., > 2 millimeters and < 4.5 millimeters). Wide-neck is defined as having a neck width > 4 millimeters or a dome-to-neck ratio < 2. These devices are available from multiple manufacturers and have been approved by FDA through the Humanitarian Device Exemption regulatory pathway, after demonstrating safety and probable benefit for their intended use.
The FDA makes recommendations to health care providers, who use neurovascular stents for SAC.
For details, please refer to the following FDA websites:
https://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm607024.htm
https://www.fda.gov/MedicalDevices/Safety/LetterstoHealthCareProviders/ucm606810.htm
If you are in possession of the affected products, please contact your supplier for necessary actions.
Posted on 9 May 2018