MAUDE manufacturer profile

BIOTRONIK AG · NIP

MAUDE profile for Stent, Superficial Femoral Artery

Key facts

Manufacturer BIOTRONIK AG
Manufacturer group BIOTRONIK AG
Product code NIP
Product code name Stent, Superficial Femoral Artery

At a glance

  • 10–99 MAUDE reports
  • 1–9 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • No Consequences Or Impact To Patient, Positioning Failure, No Clinical Signs, Symptoms or Conditions, Activation Failure, Fracture, Activation, Positioning or Separation Problem, Foreign Body In Patient, No Known Impact Or Consequence To Patient 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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