MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE
Received Jul 2, 2026 · Event occurred Jun 9, 2026
Report 3008881809-2026-00421 · MDR key 25692828
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30210
Lot number
26006144
Product problems
- Premature Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ANEURYSM PROCEDURE, RESISTANCE WAS ENCOUNTERED WHEN THE SUBJECT STENT WAS DELIVERED TO APPROXIMATELY 20CM FROM THE MICROCATHETER TIP. HOWEVER, WHEN ATTEMPTED TO RETRACT THE SUBJECT STENT DELIVERY WIRE, THE SUBJECT STENT GOT DEPLOYED WITHIN THE MICROCATHETER SHAFT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.