inforMED
MalfunctionQCA

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

Catalog 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.