SURPASS EVOLVE 4.0MM X 15MM - CE
Received May 27, 2026 · Event occurred May 8, 2026
Report 3008881809-2026-00339 · MDR key 25311538
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD40015
Lot number
25908311
Product problems
- Difficult to Insert
- Premature Activation
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING AN ICA INTERNAL CAROTID ARTERY CLINOID SEGMENT ANEURYSM PROCEDURE, AFTER THE MICROCATHETER WAS SUCCESSFULLY DELIVERED INTO POSITION AND THE PHYSICIAN PREPARED TO ADVANCE THE SUBJECT STENT, THE PHYSICIAN FOUND THAT THE STENT WAS STUCK AT THE HUB OF THE MICROCATHETER AND COULD NOT BE PUSHED FORWARD. AFTER REPEATED ADJUSTMENTS, THE FRONT HALF OF THE STENT WAS ADVANCED INTO THE STENT MICROCATHETER, BUT THEN IT GOT STUCK AND COULD NOT BE MOVED FORWARD. THE PHYSICIAN THEN PERFORMED A STENT RETRACTION OPERATION AND FOUND THAT THE STENT HAD ALREADY BEEN DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.