MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
Received Jul 6, 2026 · Event occurred Jun 11, 2026
Report 3008881809-2026-00422 · MDR key 25718935
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30150
Lot number
25281059
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 THAT WHEN THE SUBJECT STENT WAS DELIVERED TO THE TAIL END OF THE MICROCATHETER ENCOUNTERED RESISTANCE AND IT COULD NOT BE ADVANCED FURTHER. DURING ADJUSTMENTS, THE STENT DELIVERY WIRE SEPARATED FROM THE STENT CAUSING PREMATURE DEPLOYMENT. THE PHYSICIAN THEN WITHDREW THE ENTIRE STENT SYSTEM AND COMPLETED THE PROCEDURE USING A DUAL MICROCATHETER TECHNIQUE. THERE WERE NO CLINICAL CONSEQUENCES TO THE PATIENT.