SURPASS EVOLVE 4.0MM X 12MM - CE
Received Jun 22, 2026 · Event occurred May 27, 2026
Report 3008881809-2026-00384 · MDR key 25587902
Device
Generic name
Intracranial Aneurysm Flow Diverter
Manufacturer
Stryker Neurovascular CorkCatalog number
FD40012
Lot number
25575309
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
62 YR · Female
- Stenosis
Narrative
Description of Event or Problem
IT WAS REPORTED DURING THE CLINICAL TRAIL THE PATIENT UNDERWENT FLOW-DIVERTER STENT IMPLANTATION FOR RIGHT SUPRAGLENOID INTERNAL CAROTID ARTERY ANEURYSM ON (B)(6) 2025, FOLLOWED BY THE IDENTICAL PROCEDURE FOR LEFT SUPRAGLENOID INTERNAL CAROTID ARTERY ANEURYSM ON (B)(6) 2025. CEREBRAL ANGIOGRAPHY PERFORMED ON (B)(6) 2026 SHOWED SEVERE IN-STENT STENOSIS WITH SLUGGISH ANTEGRADE BLOOD FLOW WAS IDENTIFIED AT THE LEFT SIDE. NO ADVERSE CLINICAL SEQUELAE ATTRIBUTABLE TO THE STENOSIS. NO OTHER INFORMATION IS AVAILABLE.