MalfunctionOUT
SURPASS ELITE FDS 3.25MM X 12MM - PMAS
Received Jul 1, 2026 · Event occurred Jun 15, 2026
Report 3008881809-2026-00419 · MDR key 25685135
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FDSE32512
Lot number
25797976
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 PHYSICIAN WAS NOT ABLE TO RECAPTURE THE SUBJECT STENT BACK INTO THE MICROCATHETER WHEN REPOSITIONING IT. THE SUBJECT DEVICE WAS REPLACED, AND THE PROCEDURE WAS COMPLETED SUCCESSFULLY. THERE WAS A SURGICAL DELAY OF 10 MINUTES DUE TO THE REPORTED EVENT. NO CLINICAL CONSEQUENCES WERE REPORTED TO THE PATIENT DUE TO THIS EVENT.