SURPASS EVOLVE 4.0MM X 20MM - CE
Received Jun 15, 2026 · Event occurred May 25, 2026
Report 3008881809-2026-00362 · MDR key 25505432
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD40020
Lot number
26022398
Product problems
- Premature Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING ANEURYSM PROCEDURE AFTER THE SUBJECT STENT WAS DELIVERED, THE MIDDLE SEGMENT OF THE STENT WOULD NOT FULLY OPEN. THE PHYSICIAN RETRACTED THE STENT BACK AND ATTEMPTED TO REDEPLOY. WHEN ADVANCING THE STENT, THE PHYSICIAN NOTICED THE DELIVERY WIRE BECAME LIGHTER. THE STENT AND CATHETER WERE WITHDRAWN OUT OF PATIENT'S BODY FOR INSPECTION. THE MICROCATHETER WAS CUT AND FOUND THAT THE SUBJECT STENT HAD DEPLOYED INSIDE. BOTH CATHETER AND SUBJECT STENT WERE REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.