MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 24MM NO TIP - CE
Received May 22, 2026 · Event occurred Apr 29, 2026
Report 3008881809-2026-00326 · MDR key 25256358
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30240
Lot number
25713646
Product problems
- Premature Activation
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ANEURYSM PROCEDURE, RESISTANCE OCCURRED WHILE DELIVERING THE SUBJECT STENT TO THE MICROCATHETER. AFTER ADJUSTING AND UPON WITHDRAWAL, THE SUBJECT STENT GOT PARTIALLY DEPLOYED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.