inforMED
MalfunctionQCA

NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE

Received Jun 16, 2026 · Event occurred May 27, 2026

Report 3008881809-2026-00373 · MDR key 25521728

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

M003EZAS30150

Lot number

25991415

Product problems

  • Malposition of Device

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING INTRACRANIAL ANEURYSM PROCEDURE, THE PHYSICIAN USED A DOMESTIC HAILONG MICROCATHETER TO DELIVER THE SUBJECT STENT FOR STENT-ASSISTED COIL EMBOLIZATION. AFTER THE SUBJECT STENT WAS DELIVERED TO THE TARGET POSITION, THE PHYSICIAN BEGAN TO WITHDRAW THE MICROCATHETER TO DEPLOY THE SUBJECT STENT. WHEN APPROXIMATELY 3MM OF LENGTH HAD BEEN DEPLOYED, THE STENT MICROCATHETER DROPPED PROXIMALLY, AND THE SUBJECT STENT FAILED TO COVER THE ANEURYSM. THE PHYSICIAN THEN WITHDREW THE SUBJECT STENT FROM THE BODY, REPLACED IT WITH A NEW STENT, AND COMPLETED THE PROCEDURE SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.