InjuryOUT
SURPASS EVOLVE 4.5MM X 15MM - CE
Received Jun 15, 2026 · Event occurred Jun 1, 2026
Report 3008881809-2026-00369 · MDR key 25509196
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD45015
Lot number
25934153
Product problems
- Migration
Patient
Not reported
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, WHILE DEPLOYING THE STENT WHEN THE PHYSICIAN PUSHED TO ASSIST STENT OPENING THE PROXIMAL END OF THE SUBJECT STENT HERNIATED INTO THE ANEURYSM. THE PHYSICIAN IMPLANTED ANOTHER STENT TO COVER THE ANEURYSM. THE PROCEDURE WAS REPORTED TO BE COMPLETED SUCCESSFULLY, AND NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT.