inforMED
InjuryQCA

NEUROFORM ATLAS 4.5MM X 21MM NO TIP - CE

Received Jul 10, 2026 · Event occurred Jun 14, 2026

Report 3008881809-2026-00444 · MDR key 25788484

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

M003EZAS45210

Lot number

25630161

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Ruptured Aneurysm

Narrative

Description of Event or Problem

IT WAS REPORTED THAT STENT-ASSISTED COIL EMBOLIZATION WAS PERFORMED FOR A RUPTURED FUSIFORM VERTEBRAL ARTERY (VA) ANEURYSM. AFTER DEPLOYMENT OF THE SUBJECT STENT, THE ANEURYSM WALL WAS RUPTURED BY THE MICRO-GUIDEWIRE. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.