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
Manufacturer
Stryker Neurovascular CorkCatalog 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.