MAUDE manufacturer profile

MEDTRONIC HEART VALVES DIVISION · NPT

MAUDE profile for Aortic Valve, Prosthesis, Percutaneously Delivered

Key facts

Manufacturer MEDTRONIC HEART VALVES DIVISION
Manufacturer group MEDTRONIC HEART VALVES DIVISION
Product code NPT
Product code name Aortic Valve, Prosthesis, Percutaneously Delivered

At a glance

  • 1,000+ MAUDE reports
  • 1,000+ Death reports
  • 1,000+ Injury reports
  • 1,000+ Malfunction reports
  • 100–999 Problems flagged by Orca1 signal analytics
  • Adverse Event Without Identified Device or Use Problem, Patient Device Interaction Problem, Non specific EKG/ECG Changes, No Clinical Signs, Symptoms or Conditions, Device Dislodged or Dislocated, Perivalvular Leak, Insufficient Information, Valvular Insufficiency/ Regurgitation 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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