SURPASS EVOLVE 4.0MM X 17MM - CE
Received Jun 29, 2026 · Event occurred Jun 8, 2026
Report 3008881809-2026-00409 · MDR key 25660803
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD40017
Lot number
26124673
Product problems
- Difficult to Remove
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT THE SUBJECT STENT ENCOUNTERED RESISTANCE AT THE HUB OF THE FIRST MICROCATHETER. THE MICROCATHETER WAS REPLACED WITH THE NEW ONE, AND THE SUBJECT STENT WAS DELIVERED SMOOTHLY TO THE TARGET POSITION. THE SUBJECT STENT FAILED TO OPEN AT A VASCULAR CURVE. THE PHYSICIAN ATTEMPTED TO RETRIEVE THE SUBJECT STENT BUT ENCOUNTERED SIGNIFICANT RESISTANCE. AFTER MULTIPLE ATTEMPTS, THE SUBJECT STENT COULD NOT BE RETRIEVED. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.
Additional Manufacturer Narrative
THIS IS 2ND OF 2 MDRS.