MalfunctionOUT
SURPASS ELITE FDS 4.0MM X 20MM - CE
Received Jun 15, 2026 · Event occurred May 20, 2026
Report 3008881809-2026-00361 · MDR key 25501663
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FDE40020
Lot number
26060539
Product problems
- Migration
Patient
51 YR · Female
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED THAT DURING THE PROCEDURE, AFTER THE SUBJECT STENT WAS POSITIONED, IT WAS OBSERVED THAT THE STENT APPEARED TO BE DISLODGED. THE PHYSICIAN THEN IMPLANTED ANOTHER STENT TO COMPLETE THE PROCEDURE. THE PATIENT CONDITION WAS STABLE FOLLOWING PROCEDURE. NO FURTHER INFORMATION IS AVAILABLE.