MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
Received Jun 5, 2026 · Event occurred May 21, 2026
Report 3008881809-2026-00355 · MDR key 25411069
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30150
Lot number
25840413
Product problems
- Activation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT AFTER THE SUBJECT STENT WAS FULLY DEPLOYED, THE DISTAL END OF THE SUBJECT STENT DID NOT OPEN PROPERLY. THEN ADVANCED THE WIRE AND CATHETER THROUGH THE DISTAL TIP, WHICH ALLOWED IT TO EXPAND. HOWEVER, AFTER REMOVING THE WIRE AND CATHETER AGAIN, THE DISTAL TIP OF THE SUBJECT STENT COLLAPSED BACK DOWN. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.