inforMED
MalfunctionQCA

NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE

Received Jun 2, 2026 · Event occurred May 12, 2026

Report 3008881809-2026-00344 · MDR key 25362930

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

M003EZAS30150

Lot number

25960847

Product problems

  • Premature Activation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A PROCEDURE FOR A PATIENT WITH AN ANTERIOR COMMUNICATING ARTERY ANEURYSM, THE PHYSICIAN USED A GUIDEWIRE TO NAVIGATE THE MICROCATHETER TO THE LESION SITE, AND THEN ATTEMPTED TO PUSH A SUBJECT STENT THROUGH THE MICROCATHETER. WHEN THE SUBJECT STENT WAS PUSHED TO THE MIDDLE SECTION OF THE MICROCATHETER, DIFFICULTY IN PUSHING WAS ENCOUNTERED. THE SUBJECT STENT WAS MOVABLE BUT COULD NOT BE ADVANCED. THE PHYSICIAN RETRACTED THE GUIDEWIRE AND FOUND THAT THE SUBJECT STENT HAD DETACHED WITHIN THE MICROCATHETER. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.