inforMED
MalfunctionOUT

SURPASS EVOLVE 4.0MM X 15MM - CE

Received May 27, 2026 · Event occurred May 8, 2026

Report 3008881809-2026-00339 · MDR key 25311538

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FD40015

Lot number

25908311

Product problems

  • Difficult to Insert
  • Premature Activation

Patient

NA · Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT DURING AN ICA INTERNAL CAROTID ARTERY CLINOID SEGMENT ANEURYSM PROCEDURE, AFTER THE MICROCATHETER WAS SUCCESSFULLY DELIVERED INTO POSITION AND THE PHYSICIAN PREPARED TO ADVANCE THE SUBJECT STENT, THE PHYSICIAN FOUND THAT THE STENT WAS STUCK AT THE HUB OF THE MICROCATHETER AND COULD NOT BE PUSHED FORWARD. AFTER REPEATED ADJUSTMENTS, THE FRONT HALF OF THE STENT WAS ADVANCED INTO THE STENT MICROCATHETER, BUT THEN IT GOT STUCK AND COULD NOT BE MOVED FORWARD. THE PHYSICIAN THEN PERFORMED A STENT RETRACTION OPERATION AND FOUND THAT THE STENT HAD ALREADY BEEN DEPLOYED. THE PROCEDURE WAS COMPLETED SUCCESSFULLY BY REPLACING THE SUBJECT DEVICE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.