inforMED
InjuryOUT

SURPASS EVOLVE 4.5MM X 17MM - CE

Received Jun 15, 2026 · Event occurred May 14, 2026

Report 3008881809-2026-00367 · MDR key 25508159

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FD45017

Lot number

25934142

Product problems

  • Malposition of Device

Patient

Unknown

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

DURING AN ICA INTERNAL CAROTID ARTERY ANEURYSM PROCEDURE, AFTER DELIVERING THE SUBJECT STENT TO THE PRESET POSITION THROUGH THE MICROCATHETER, THE PHYSICIAN BEGAN TO DEPLOY THE STENT. WHEN DEPLOYING THE STENT PAST THE RECAPTURE POINT, THE STENT SUDDENLY JUMPED FORWARD DUE TO THE TENSION ACCUMULATED IN THE DELIVERY WIRE, AND THE DEPLOYMENT POSITION DEVIATED SIGNIFICANTLY FROM THE PRESET POSITION, RESULTING IN STENT FORESHORTENING THAT COULD ONLY COVER A SMALL PART OF THE ANEURYSM NECK. THEREFORE, THE PHYSICIAN DEPLOYED AN ADDITIONAL STENT TO COMPLETE THE PROCEDURE. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.