MAUDE manufacturer profile

EDWARDS LIFESCIENCES · NPW

MAUDE profile for Percutaneously Delivered Prostheses And Tricuspid Valves

Key facts

Manufacturer EDWARDS LIFESCIENCES
Manufacturer group EDWARDS LIFESCIENCES
Product code NPW
Product code name Percutaneously Delivered Prostheses And Tricuspid Valves

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 1–9 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Patient Device Interaction Problem, Heart Block, Malposition of Device, Migration, Failure of Implant, Bradycardia, Thrombosis/Thrombus, Cardiac Perforation 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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