NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
Received Jun 3, 2026 · Event occurred Apr 9, 2026
Report 3008881809-2026-00346 · MDR key 25374643
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30210
Lot number
UNKNOWN
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Stroke/CVA
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING COIL EMBOLIZATION CASE, THE SUBJECT STENT WAS DEPLOYED; HOWEVER, RE-OCCLUSION OCCURRED DUE TO THROMBUS FORMATION APPROXIMATELY 10 MINUTES LATER. A MICROCATHETER WAS ADVANCED THROUGH THE STENT, WHICH RESULTED IN RECANALIZATION. AN INFARCT WAS IDENTIFIED IN THE LEFT FRONTAL LOBE, WITH RESIDUAL RIGHT-SIDED PARALYSIS. THE PATIENT¿S SYMPTOMS IMPROVED WITH REHABILITATION, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO A REHABILITATION HOSPITAL. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 30 MIN DUE TO THE REPORTED EVENT.