NEUROFORM ATLAS 3.0MM X 15MM NO TIP - CE
Received Jul 10, 2026 · Event occurred Jun 23, 2026
Report 3008881809-2026-00445 · MDR key 25788601
Device
Generic name
Intracranial Coil-assist Stent
Manufacturer
Stryker Neurovascular CorkCatalog number
M003EZAS30150
Lot number
24349381
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Intracranial Hemorrhage
- Thrombosis/Thrombus
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN MIDDLE CEREBRAL ARTERY SUBARACHNOID HEMORRHAGE ANEURYSM TREATMENT USING A TRANSCELL TECHNIQUE. HOWEVER, THROMBUS FORMATION WAS OBSERVED AFTER PLACEMENT OF THE COILS, RESULTING IN LOSS OF M2 VISUALIZATION. THE PHYSICIAN USED PHARMACOLOGIC TREATMENT AND THE THROMBUS GOT RESOLVED. HOWEVER, AN INTRACRANIAL HEMORRHAGE OCCURRED, AND THE TREATMENT WAS CONVERTED TO CRANIOTOMY JUST BEFORE COMPLETION OF THE PROCEDURE. THE PHYSICIAN PERFORMED ANEURYSM CLIPPING, HEMATOMA EVACUATION, AND DECOMPRESSIVE CRANIECTOMY. THE PATIENT'S CONDITION WAS REPORTED TO BE POOR, AND ONGOING BLEEDING WAS REPORTED. AN ADDITIONAL TREATMENT IS EXPECTED TO BE REQUIRED. NO FURTHER INFORMATION WAS REPORTED.
Additional Manufacturer Narrative
THIS IS 2 OF 2 REPORTS (2ND MDR).