SURPASS EVOLVE 4.5MM X 30MM - CE
Received Jul 20, 2026 · Event occurred Jun 24, 2026
Report 3008881809-2026-00466 · MDR key 25874193
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD45030
Lot number
25574545
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
Not reported
- Thrombosis/Thrombus
Narrative
Additional Manufacturer Narrative
THIS IS 1 OF 2 REPORTS.
Description of Event or Problem
IT WAS REPORTED THAT DURING VERTEBRAL ARTERY (VA) ANEURYSM PROCEDURE, THE SUBJECT STENT HAD RESISTANCE WHILE PASSING THE MICROCATHETER HUB AND INSIDE THE CATHETER. THE CATHETER SHIFTED, SO THE PHYSICIAN WITHDRAW BOTH THE CATHETER AND THE STENT. OUTSIDE THE PATIENT, THE STENT WAS DEPLOYED FROM THE CATHETER, AND MULTIPLE THROMBUS WAS FOUND INSIDE THE STENT. BOTH DEVICES WERE REPLACED AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.