Dear ASNR Members,
ASNR was recently contacted by the Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH), Office of Product Evaluation and Quality (OPEQ), Office of Neurological and Physical Medicine Devices (OHT5) about ongoing post-market surveillance regarding the MicroVention Woven EndoBridge (WEB) Aneurysm Embolization System.
On December 18, 2019 MicroVention released a letter to healthcare providers to provide an update on product performance and reported adverse events and to advise healthcare practitioners on best practices. Specifically, 6 intra-procedural, intracranial aneurysm ruptures caused by aneurysm wall perforation were reported to MicroVention in 2019 that resulted in patient deaths due to iatrogenic intra-procedural subarachnoid hemorrhage – 4 in the US and 2 outside of the US. Please see the attached letter for additional details.
User facilities should report device-related deaths and serious injuries to MicroVention (the manufacturer), at firstname.lastname@example.org. Device-related deaths should also be reported to the FDA. Voluntary reports can be submitted through MedWatch, the FDA Safety Information and Adverse Event Reporting program (https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program/reporting-serious-problems-fda).
We request that members follow the attached guidance and report any adverse events. Please feel free to reach out to us with any questions or comments.
American Society of Neuroradiology (ASNR)