SURPASS EVOLVE 4.5MM X 20MM - CE
Received May 22, 2026 · Event occurred May 12, 2026
Report 3008881809-2026-00334 · MDR key 25259641
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD45020
Lot number
25679596
Product problems
- Premature Activation
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE PROCEDURE WHEN THE SUBJECT STENT WAS DEPLOYED AT THE TREATMENT SITE, THE TIP OPENED BUT THE MIDDLE WOULD NOT. THE PHYSICIAN REPEATEDLY PUSHED AND PULLED TO INCREASE AND RELEASE TENSION, BUT THE STENT WOULD NOT OPEN NOT OPEN. THE ENTIRE STENT WAS RETRACTED INTO THE MICROCATHETER AND THE PHYSICIAN FOUND THAT THE STENT AND DELIVERY WIRE HAD SEPARATED CAUSING THE STENT TO DEPLOY INSIDE THE MICROCATHETER. THE STENT AND CATHETER WERE REMOVED FROM THE PATIENT. SUBJECT STENT WAS REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT