MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
Received Jun 8, 2026 · Event occurred May 25, 2026
Report 3008881809-2026-00356 · MDR key 25428580
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30210
Lot number
26006142
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REPORTED DURING THE PROCEDURE THEN THE PHYSICIAN WAS ADJUSTING AND POSITIONING THE SUBJECT STENT, THE DELIVERY WIRE WAS WITHDRAWN RESULTING IN PREMATURE DEPLOYMENT OF THE STENT INSIDE THE MICROCATHETER. THE MICROCATHETER AND STENT WERE WITHDRAWN AND REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.