inforMED
MalfunctionQCA

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

Catalog 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.