Stent, Coronary

What the Data Shows About Stent, Coronary

The FDA MAUDE database aggregates 23,266 adverse-event reports for Stent, Coronary spanning the period from 1993 through 2026. Of these, 1,758 are classified as death reports, 11,927 as injury reports, and 9,397 as malfunction reports under FDA adverse-event categorization rules. Report counts do not by themselves indicate a device is unsafe — widely used devices and longer market histories naturally generate larger raw counts, so proportional and comparative reads are more informative than totals alone.

The adverse-event profile breaks down across 5 distinct event types and 15 reported patient-outcome categories, giving a multi-dimensional view that goes beyond a single headline number. A total of 20 distinct product-problem codes appear in the reports, with Failure to Advance topping the list at 1,610 reports. Reports are associated with 10 different manufacturers in the MAUDE record, reflecting both OEMs and repackagers of this device category.

Annual reporting volume is tracked across 34 years of MAUDE data, with the peak single-year volume reaching 1,568 reports — trend shape often reflects changes in device adoption, reporting rules, or FDA enforcement focus rather than underlying device behavior alone. Events are documented across 17 reported care-setting categories (hospital, home, ambulatory surgery center, etc.). All figures reflect the openFDA MAUDE snapshot last refreshed on 2026-05-15. This page is informational and is not medical advice — discuss device-safety questions with your healthcare provider.