MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
Received Jun 3, 2026 · Event occurred May 12, 2026
Report 3008881809-2026-00347 · MDR key 25375072
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30210
Lot number
26006929
Product problems
- Premature Activation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PROCEDURE WHILE DELIVERING THE SUBJECT STENT INTO THE CATHETER, THERE WAS RESISTANCE. WHEN THE PHYSICIAN RETRACTED THE STENT, IT WAS FOUND HALF DEPLOYED IN THE CATHETER AND HALF IN THE INTRODUCING SHEATH. THE DEVICE WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.