MAUDE brand profile
EDWARDS SAPIEN XT TRANSCATHETER HEART VLV 26MM
MAUDE brand safety profile
Key facts
| Brand name | EDWARDS SAPIEN XT TRANSCATHETER HEART VLV 26MM |
|---|
At a glance
- 10–99 MAUDE reports
- 1–9 Death reports
- 10–99 Injury reports
- 1–9 Malfunction reports
- 10–99 Problems coded
- 10–99 Problems flagged by Orca1 signal analytics
- Malposition of Device, Perivalvular Leak, Aortic Regurgitation, Adverse Event Without Identified Device or Use Problem, Injury, Aortic Insufficiency, No Known Impact Or Consequence To Patient, Device Dislodged or Dislocated Most reported problems
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About MAUDE brand safety profiles
Brand profiles aggregate every MAUDE report that names the brand, so you can compare report volumes and problem patterns across devices. Reports are unverified and do not by themselves establish causation.
Source: U.S. Food and Drug Administration (FDA), MAUDE database; aggregation by Orca1