inforMED
InjuryOUT

SURPASS EVOLVE 5.0MM X 25MM - CE

Received Jul 21, 2026 · Event occurred May 26, 2026

Report 3008881809-2026-00471 · MDR key 25894286

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FD50025

Lot number

25679598

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

Not reported

  • Stroke/CVA
  • Dizziness
  • Stenosis

Narrative

Description of Event or Problem

IT WAS REPORTED IN THE CLINICAL TRAIL AT POST PROCEDURE FOLLOW-UP THE PATIENT SUFFERED AN ISCHEMIC STROKE AND STENOSIS WAS FOUND ON IMAGING. THE PATIENT EXPERIENCED DIZZINESS FOR 1 DAY. NO OTHER INFORMATION IS AVAILABLE.