MalfunctionQCA
NEUROFORM ATLAS 4.0MM X 21MM NO TIP - CE
Received Jun 8, 2026 · Event occurred May 14, 2026
Report 3008881809-2026-00357 · MDR key 25437009
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS40210
Lot number
26061467
Product problems
- Activation Failure
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE, WHEN TRIED TO PLACE THE SUBJECT STENT, IT GOT STUCK IN THE MICROCATHETER AND COULD NOT BE OPENED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.