MAUDE brand profile

OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

MAUDE brand safety profile

Key facts

Brand name OVATION PRIME ABDOMINAL STENT GRAFT SYSTEM

At a glance

  • 100–999 MAUDE reports
  • 10–99 Death reports
  • 100–999 Injury reports
  • 10–99 Malfunction reports
  • 10–99 Problems coded
  • 10–99 Problems flagged by Orca1 signal analytics
  • Aneurysm, Hemorrhage/Blood Loss/Bleeding, Leak/Splash, Adverse Event Without Identified Device or Use Problem, Malposition of Device, Insufficient Information, Occlusion Within Device, Occlusion 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

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