inforMED
MalfunctionOUT

SURPASS EVOLVE 4.0MM X 20MM - CE

Received Jun 15, 2026 · Event occurred May 25, 2026

Report 3008881809-2026-00362 · MDR key 25505432

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FD40020

Lot number

26022398

Product problems

  • Premature Activation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING ANEURYSM PROCEDURE AFTER THE SUBJECT STENT WAS DELIVERED, THE MIDDLE SEGMENT OF THE STENT WOULD NOT FULLY OPEN. THE PHYSICIAN RETRACTED THE STENT BACK AND ATTEMPTED TO REDEPLOY. WHEN ADVANCING THE STENT, THE PHYSICIAN NOTICED THE DELIVERY WIRE BECAME LIGHTER. THE STENT AND CATHETER WERE WITHDRAWN OUT OF PATIENT'S BODY FOR INSPECTION. THE MICROCATHETER WAS CUT AND FOUND THAT THE SUBJECT STENT HAD DEPLOYED INSIDE. BOTH CATHETER AND SUBJECT STENT WERE REPLACED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY WITH NO CLINICAL CONSEQUENCES TO THE PATIENT.