MalfunctionOUT
SURPASS ELITE FDS 4.25MM X 20MM - PMAS
Received May 22, 2026 · Event occurred May 7, 2026
Report 3008881809-2026-00325 · MDR key 25251403
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FDSE42520
Lot number
25725555
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 FAILED TO OPEN AND WAS TACKED DOWN TO SUBJECT STENT DELIVERY WIRE. UPON RESHEATHING THE PHYSICIAN EXPERIENCED RESISTANCE AND NOTICED THE SUBJECT STENT DELIVERY WIRE MOVE MORE DISTAL WHILE THE DEVICE WAS NOT RECAPTURING. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.