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
Manufacturer
Stryker Neurovascular CorkCatalog 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.