inforMED
InjuryQCA

NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE

Received Jun 11, 2026 · Event occurred Apr 27, 2026

Report 3008881809-2026-00359 · MDR key 25477955

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

M003EZAS30210

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem
  • Insufficient Device Problem Information

Patient

Not reported

  • Stroke/CVA
  • Obstruction/Occlusion
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT PATIENT PRESENTED WITH RUPTURED ANTERIOR COMMUNICATING ARTERY (ACOMA) ANEURYSM. THE SUBJECT STENT WAS DEPLOYED, AND FOUR COILS WERE PLACED ACHIEVING AN ACCEPTABLE EMBOLIZATION RESULT, AND THE PROCEDURE WAS CONCLUDED. ALTHOUGH DELAYED FLOW IN THE ANTERIOR CEREBRAL ARTERY (ACA) WAS OBSERVED ON THE FINAL ANGIOGRAPHY, NO APPARENT THROMBUS WAS NOTED. ON THE FOLLOWING DAY (APRIL 27), MAGNETIC RESONANCE IMAGING (MRI) REVEALED ANTERIOR CEREBRAL ARTERY (ACA) OCCLUSION WITH CEREBRAL INFARCTION. THE PATIENT HAS HIGHER CORTICAL DYSFUNCTION, INCLUDING DECREASED MOTIVATION, DISINHIBITION, AND ATTENTION DEFICIT.