inforMED
MalfunctionPOL

TREVO NXT 6MM X 37MM - CE

Received Mar 19, 2026 · Event occurred Feb 19, 2026

Report 3012931345-2026-00050 · MDR key 24638344

Device

Generic name

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Catalog number

90415

Lot number

0000633882

Product problems

  • Fracture

Patient

NA · Unknown

  • Foreign Body In Patient

Narrative

Description of Event or Problem

IT WAS REPORTED THAT THE STENT (SUBJECT DEVICE) WAS USED IN THE MEDICAL PROCEDURE. HOWEVER, THE SUBJECT DEVICE GOT CAUGHT IN THE CALCIFICATION IN INTERNAL CAROTID ARTERY (ICA) AND BROKE FREE FROM THE PUSHER WIRE AND STAYED WITHIN THE ICA. THE CALCIFICATION WAS REPORTED TO BE A PRE-EXISTING CONDITION TO THE PATIENT. NO ATTEMPT WAS MADE TO REMOVE THE BROKEN FRAGMENT OF THE SUBJECT DEVICE. THE PATIENT WAS REPORTED TO BE DOING WELL WITH (MODIFIED RANKIN SCALE) MRS SCORE OF 2 FROM PREPROCEDURAL MRS OF 12. NO FURTHER INFORMATION AVAILABLE.