NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE
Received May 22, 2026 · Event occurred May 6, 2026
Report 3008881809-2026-00335 · MDR key 25260016
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS45210
Lot number
25934816
Product problems
- Premature Activation
Patient
68 YR · Male
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN INTRACRANIAL POSTERIOR COMMUNICATING ARTERY ANEURYSM EMBOLIZATION PROCEDURE, AFTER THE MICROCATHETER WAS SUCCESSFULLY POSITIONED, THE SUBJECT STENT WAS DELIVERED TO ASSIST WITH EMBOLIZATION. WHEN THE STENT HAD ENTERED APPROXIMATELY 1 CM INTO THE MICROCATHETER, RESISTANCE WAS ENCOUNTERED DURING DELIVERY, AND THE ADVANCEMENT WAS OBSTRUCTED. THE PHYSICIAN HAD TO WITHDRAW THE DELIVERY WIRE OF THE STENT, RESULTING IN THE STENT BEING DEPLOYED INSIDE THE MICROCATHETER. SUBSEQUENTLY, THE PHYSICIAN REPLACED IT WITH ANOTHER STENT AND SUCCESSFULLY COMPLETED THE PROCEDURE WITHOUT ANY CLINICAL CONSEQUENCES TO THE PATIENT.