inforMED
InjuryOUT

SURPASS EVOLVE 4.0MM X 25MM - CE

Received Jun 9, 2026 · Event occurred May 17, 2026

Report 3008881809-2026-00358 · MDR key 25445842

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FD40025

Lot number

25934158

Product problems

  • Fracture

Patient

Female

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING ONE INTERNAL CAROTID ARTERY (ICA) ANEURYSM. AFTER THE SUBJECT STENT WAS DELIVERED TO THE TARGET POSITION AND WHILE RETRACTING THE MICROCATHETER TO DEPLOY THE STENT, RESISTANCE OCCURRED. THE PHYSICIAN SLOWLY RETRACTED THE MICROCATHETER AND FOUND THAT THE TIP OF THE SUBJECT STENT DELIVERY SYSTEM BROKE DURING THE PROCESS. THE BROKEN PART WAS RETRIEVED USING AN ENDOVASCULAR RETRIEVAL DEVICE. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.