NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
Received Jun 2, 2026 · Event occurred May 12, 2026
Report 3008881809-2026-00344 · MDR key 25362930
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30150
Lot number
25960847
Product problems
- Premature Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING A PROCEDURE FOR A PATIENT WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN USED A GUIDEWIRE TO NAVIGATE THE MICROCATHETER TO THE LESION SITE, AND THEN ATTEMPTED TO PUSH A SUBJECT STENT THROUGH THE MICROCATHETER. WHEN THE SUBJECT STENT WAS PUSHED TO THE MIDDLE SECTION OF THE MICROCATHETER, DIFFICULTY IN PUSHING WAS ENCOUNTERED. THE SUBJECT STENT WAS MOVABLE BUT COULD NOT BE ADVANCED. THE PHYSICIAN RETRACTED THE GUIDEWIRE AND FOUND THAT THE SUBJECT STENT HAD DETACHED WITHIN THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.