NEUROFORM ATLAS 4.0MM X 24MM NO TIP - CE
Received Jun 24, 2026 · Event occurred Jun 3, 2026
Report 3008881809-2026-00395 · MDR key 25611887
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS40240
Lot number
25574285
Product problems
- Premature Activation
Patient
80 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT A PATIENT WITH A VERTEBRAL ARTERY (VA) ANEURYSM WAS SCHEDULED FOR STENT IMPLANTATION. DURING ADVANCEMENT OF THE SUBJECT STENT INTO THE MICROCATHETER, THE SUBJECT STENT BECAME STUCK AT THE MICROCATHETER ENTRANCE AND COULD NOT BE PUSHED FORWARD. REPEATED ADJUSTMENTS DID NOT IMPROVE THE SITUATION. THE PHYSICIAN ATTEMPTED TO RETRACT THE SUBJECT STENT SYSTEM, BUT RETRACTION FAILED; THE SUBJECT STENT REMAINED STUCK AT THE MICROCATHETER ENTRANCE (PARTIALLY WITHIN THE MICROCATHETER LUMEN AND PARTIALLY WITHIN THE TRANSPARENT HUB), AND THE DELIVERY WIRE SEPARATED FROM THE SUBJECT STENT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.