inforMED
InjuryOUT

SURPASS ELITE FDS 3.75MM X 15MM - PMAS

Received Jun 26, 2026 · Event occurred Jun 3, 2026

Report 3008881809-2026-00402 · MDR key 25635614

Device

Generic name

Intracranial Aneurysm Flow Diverter

Catalog number

FDSE37515

Lot number

UNKNOWN

Product problems

  • Adverse Event Without Identified Device or Use Problem

Patient

NA · Unknown

  • Stroke/CVA

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE PATIENT HAD STROKE POST 20 HOURS AFTER PROCEDURE. NO ADDITIONAL INFORMATION AVAILABLE. THERE WAS UNKNOWN INTERVENTION REQUIRED DUE TO THE REPORTED EVENT.