MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
Received May 22, 2026 · Event occurred May 11, 2026
Report 3008881809-2026-00330 · MDR key 25257094
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30150
Lot number
25960849
Product problems
- Premature Activation
Patient
59 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHEN HALF OF THE STENT ENTERED THE MICROCATHETER FURTHER DELIVERY BECAME DIFFICULT. THE PHYSICIAN ADJUSTED THE DELIVERY WIRE AND FOUND THE SUBJECT STENT TO BE DEPLOYED WITHIN THE PROXIMAL END OF MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED ALONG WITH THE MICROCATHETER, AND THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.