inforMED
InjuryOUT

SURPASS EVOLVE 4.5MM X 17MM - CE

Received Jul 8, 2026 · Event occurred Jun 16, 2026

Report 3008881809-2026-00430 · MDR key 25756802

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FD45017

Lot number

25354069

Product problems

  • Malposition of Device

Patient

Not reported

  • No Clinical Signs, Symptoms or Conditions

Narrative

Description of Event or Problem

IT WAS REPORTED THAT AFTER THE SUCCESSFUL DEPLOYMENT OF THE SUBJECT STENT, THE PHYSICIAN FOUND SLIGHT CURLING AT THE SUBJECT STENT TAIL END, SO A GUIDEWIRE WAS USED FOR MASSAGE. AFTER MASSAGING, ANGIOGRAPHY REVEALED ABNORMAL SHORTENING OF THE SUBJECT STENT, WHICH COULD NOT COVER THE ANEURYSM NECK. THE PHYSICIAN THEN IMPLANTED AN ADDITIONAL STENT TO COVER THE NECK OF ANEURYSM. THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 30 MIN DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.