MAUDE manufacturer profile

HEART VALVES SANTA ANA · NPV

MAUDE profile for Pulmonary Valve Prosthesis Percutaneously Delivered

Key facts

Manufacturer HEART VALVES SANTA ANA
Manufacturer group HEART VALVES SANTA ANA
Product code NPV
Product code name Pulmonary Valve Prosthesis Percutaneously Delivered

At a glance

  • 10–99 MAUDE reports
  • 1–9 Death reports
  • 10–99 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems flagged by Orca1 signal analytics
  • Insufficient Information, Pulmonary Valve Stenosis, Endocarditis, Gradient Increase, Patient Device Interaction Problem, Pulmonary Regurgitation, Fracture, Adverse Event Without Identified Device or Use Problem 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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