SURPASS EVOLVE 4.5MM X 17MM - CE
Received Jun 15, 2026 · Event occurred May 14, 2026
Report 3008881809-2026-00367 · MDR key 25508159
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD45017
Lot number
25934142
Product problems
- Malposition of Device
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
DURING AN ICA INTERNAL CAROTID ARTERY ANEURYSM PROCEDURE, AFTER DELIVERING THE SUBJECT STENT TO THE PRESET POSITION THROUGH THE MICROCATHETER, THE PHYSICIAN BEGAN TO DEPLOY THE STENT. WHEN DEPLOYING THE STENT PAST THE RECAPTURE POINT, THE STENT SUDDENLY JUMPED FORWARD DUE TO THE TENSION ACCUMULATED IN THE DELIVERY WIRE, AND THE DEPLOYMENT POSITION DEVIATED SIGNIFICANTLY FROM THE PRESET POSITION, RESULTING IN STENT FORESHORTENING THAT COULD ONLY COVER A SMALL PART OF THE ANEURYSM NECK. THEREFORE, THE PHYSICIAN DEPLOYED AN ADDITIONAL STENT TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.