inforMED
MalfunctionQCA

NEUROFORM ATLAS 3.0MM X 21MM NO TIP - CE

Received May 27, 2026 · Event occurred May 6, 2026

Report 3008881809-2026-00338 · MDR key 25300565

Device

Generic name

Intracranial Coil-assist Stent

Catalog number

M003EZAS30210

Lot number

25603713

Product problems

  • Activation Failure

Patient

63 YR · Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING A POSTERIOR COMMUNICATING ARTERY ANEURYSM EMBOLIZATION, THE SUBJECT STENT WAS DELIVERED TO THE TARGET POSITION. WHEN THE PHYSICIAN RETRACTED THE MICROCATHETER, THE SUBJECT STENT TIP COULD NOT OPEN. AFTER REPEATED ADJUSTMENTS, THE SUBJECT STENT TIP STILL COULD NOT OPEN. THE PHYSICIAN THEN USED AN INTERMEDIATE CATHETER TO RETRIEVE THE ENTIRE SUBJECT STENT OUT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.