SURPASS EVOLVE 4.0MM X 25MM - CE
Received Jun 9, 2026 · Event occurred May 17, 2026
Report 3008881809-2026-00358 · MDR key 25445842
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD40025
Lot number
25934158
Product problems
- Fracture
Patient
Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING ONE INTERNAL CAROTID ARTERY (ICA) ANEURYSM. AFTER THE SUBJECT STENT WAS DELIVERED TO THE TARGET POSITION AND WHILE RETRACTING THE MICROCATHETER TO DEPLOY THE STENT, RESISTANCE OCCURRED. THE PHYSICIAN SLOWLY RETRACTED THE MICROCATHETER AND FOUND THAT THE TIP OF THE SUBJECT STENT DELIVERY SYSTEM BROKE DURING THE PROCESS. THE BROKEN PART WAS RETRIEVED USING AN ENDOVASCULAR RETRIEVAL DEVICE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.