MalfunctionQCA
NEUROFORM ATLAS 3.0MM X 21MM NO TIP- PMA
Received Jun 12, 2026 · Event occurred May 20, 2026
Report 3008881809-2026-00360 · MDR key 25493055
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003UZAS30210
Lot number
25976642
Product problems
- Difficult or Delayed Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING PROCEDURE, THE SUBJECT STENT DID NOT DEPLOY AS EXPECTED AND IT WAS RE-SHEATHED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.