inforMED
InjuryQCA

NEUROFORM ATLAS 3.0MM X 24MM NO TIP- PMA

Received Jun 16, 2026 · Event occurred May 28, 2026

Report 3008881809-2026-00371 · MDR key 25519894

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

M003UZAS30240

Lot number

26006494

Product problems

  • Fracture

Patient

40 YR · Male

  • Foreign Body In Patient
  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING THE PROCEDURE WHILE DEPLOYING THE SUBJECT STENT, THE SUBJECT STENT BROKE. THE PHYSICIAN TAKED DOWN THE BROKEN PART OF THE SUBJECT STENT LEFT IN THE PATIENT WITH ANOTHER ATLAS DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT. THERE IS NO ADDITIONAL INFORMATION AVAILABLE.