inforMED
InjuryPOL

TREVO NXT6MM X 57MM

Received Mar 2, 2021 · Event occurred Feb 13, 2021

Report MW5099729 · MDR key 11404107

Device

Generic name

Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Lot number

000005241910

Product problems

  • Difficult to Remove

Patient

62 YR

  • Foreign Body In Patient
  • Foreign Body In Patient

Narrative

Description of Event or Problem

PT HAD EXTENDED WINDOW ELVO. ABLE TO REMOVE CLOT FROM MCA. WHEN TRYING TO REMOVE CLOT FROM RMI, TREVO DEVICE ENGAGED CLOT, BROKE OFF, AND WAS LEFT IN THE MI. SEVERAL ATTEMPTS MADE TO REMOVE WITHOUT SUCCESS. FDA SAFETY REPORT ID# (B)(4).