MAUDE manufacturer profile

MICRO THERAPEUTICS, INC. DBA EV3 · POL

MAUDE profile for Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

Key facts

Manufacturer MICRO THERAPEUTICS, INC. DBA EV3
Manufacturer group MICRO THERAPEUTICS, INC. DBA EV3
Product code POL
Product code name Neurovascular Mechanical Thrombectomy Device For Acute Ischemic Stroke Treatment

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Break, Detachment of Device or Device Component, Adverse Event Without Identified Device or Use Problem, Vasoconstriction, Unspecified Nervous System Problem, Embolism/Embolus, Intracranial Hemorrhage, Perforation of Vessels Most reported problems

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

About MAUDE manufacturer and product code profiles

Manufacturer profiles aggregate MAUDE reports for one manufacturer within one product code, the level at which device safety signals are usually reviewed.

Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1

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