Prosthesis, Mitral Valve, Percutaneously Delivered
Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.
OpenFDA device adverse-event casebook.
FDA MAUDE casebook
openFDA event book Prosthesis LIGHT-BOOK · MAUDE
#508 of 1000 · 1,930 reports · 2017–2026
- BOOK 1,930 reports
- RANK #508 of 1000
- DEATH 415 death-typed
- INJ 1,377 injury-typed
- MALF 138 malfunction
- SPAN 2017–2026
- PEAK 2025: 315
- PHOTO Radioimmunoassay
Nearest event-volume peer: Radioimmunoassay, Free Thyroxine (8 report gap)
Prosthesis, Mitral Valve, Percutaneously Delivered sits #508 of 1000 among tracked device types with 1,930 MAUDE reports spanning 2017–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →
Malfunction reports sit below the device-type norm
Prosthesis carries 7.2% MALFUNCTION-coded reports, 57.7pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 21.5% corpus 1.5% · above corpus mean (+20.0 pp)
- INJ 71.3% corpus 30.3% · above corpus mean (+41.1 pp)
- MALF 7.2% corpus 64.8% · below corpus mean (-57.7 pp)
Lead product-problem code Adverse Event Without Identified Device or Use Problem is 34% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 64% of manufacturer-tagged reports · Top event location is 74% of location-tagged rows .
Prosthesis in the event-volume neighbourhood
FDA MAUDE report totals among this device type and nearest nationwide peers
- Radioimmunoas…
Radioimmunoassay, Total Triiodothyronine
1,979 reports
- Tubes
Tubes, Vacuum Sample, With Anticoagulant
1,965 reports
- Prosthesis (this)
Prosthesis, Mitral Valve, Percutaneously Delivered
1,930 reports
- Radioimmunoas…
Radioimmunoassay, Free Thyroxine
1,922 reports
- Calculator
Calculator, Drug Dose
1,898 reports
- Ventilator
Ventilator, Emergency, Manual (Resuscitator)
1,891 reports
What this shows Prosthesis, Mitral Valve, Percutaneously Delivered carries 1,930 MAUDE reports, ranked #508 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports in 2025 (315) held close to the prior two-year average of 284.
Related Entities for Prosthesis, Mitral Valve, Percutaneously Delivered
Top Manufacturers
Event Locations
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Prosthesis: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.
Similar report volume
Nearest other device types by FDA MAUDE report count (1,930 here).
Similar death-typed counts
Nearest other device types by death-typed report count (415 here), distinct from the volume row.
Read our methodology - how this data is sourced, computed, and verified.
Disclaimer: MAUDE figures for Prosthesis are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.
Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.