MAUDE manufacturer profile
BOSTON SCIENTIFIC CORPORATION · NPT
MAUDE profile for Aortic Valve, Prosthesis, Percutaneously Delivered
Key facts
| Manufacturer | BOSTON SCIENTIFIC CORPORATION |
|---|---|
| Manufacturer group | BOSTON SCIENTIFIC IRELAND LIMITED |
| Product code | NPT |
| Product code name | Aortic Valve, Prosthesis, Percutaneously Delivered |
At a glance
- 1,000+ MAUDE reports
- 100–999 Death reports
- 100–999 Injury reports
- 100–999 Malfunction reports
- 10–99 Problems flagged by Orca1 signal analytics
- Adverse Event Without Identified Device or Use Problem, Arrhythmia, Complete Heart Block, No Consequences Or Impact To Patient, Death, Perivalvular Leak, Stroke/CVA, Material Deformation 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