MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE
Received May 22, 2026 · Event occurred May 11, 2026
Report 3008881809-2026-00329 · MDR key 25257096
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30240
Lot number
25713648
Product problems
- Difficult or Delayed Activation
Patient
61 YR · Male
- 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, ONCE TIP OF THE STENT WAS DEPLOYED RESISTANCE WAS ENCOUNTERED AND FURTHER DEPLOYMENT COULD NOT BE CONTINUED. 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.