MalfunctionOUT
UNKNOWN_NEUROVASCULAR_PRODUCT
Received Jul 9, 2026 · Event occurred Jun 5, 2026
Report 3008881809-2026-00435 · MDR key 25765548
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
UNK_NEU
Product problems
- Deformation Due to Compressive Stress
- Migration
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE FOR SACCULAR SIDEWALL ANEURYSMS. THE PROCEDURE WAS COMPLETED SUCCESSFULLY HOWEVER ON FOLLOWUP AFTER 6 MONTHS IT WAS REPORTED THAT THERE WAS A SLIGHT PROXIMAL SHIFT IN THE DEPLOYED STENT AND THE DISTAL END OF THE STENT APPEARS TO BE FISH MOUTHED. THE PATIENT WAS REPORTED TO BE ASYMPTOMATIC AND THE ANEURYSMS WERE REPORTED TO BE HEALING.