2026 data FDA MAUDE openFDA

Ring, Annuloplasty

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 Ring, Annuloplasty LIGHT-BOOK · MAUDE

#220 of 1000 · 9,471 reports · 1994–2026

  • BOOK 9,471 reports
  • RANK #220 of 1000
  • DEATH 777 death-typed
  • INJ 8,340 injury-typed
  • MALF 184 malfunction
  • SPAN 1994–2026
  • PEAK 2008: 1,288
  • PHOTO Plate, Bone

Nearest event-volume peer: Plate, Bone (4 report gap)

Ring, Annuloplasty sits #220 of 1000 among tracked device types with 9,471 MAUDE reports spanning 1994–2026. 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 →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 8.2% corpus 1.5% · above corpus mean (+6.7 pp)
  • INJ 88.1% corpus 30.4% · above corpus mean (+57.6 pp)
  • MALF 1.9% corpus 64.5% · below corpus mean (-62.6 pp)

Lead product-problem code Insufficient Information is 50% of coded problems · Lead manufacturer EDWARDS LIFESCIENCES accounts for 58% of manufacturer-tagged reports · Top event location HOSPITAL is 52% of location-tagged rows .

Ring, Annuloplasty in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Ring, Annuloplasty carries 9,471 MAUDE reports, ranked #220 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 8,340 (88.1%)
Death 777 (8.2%)
Malfunction 184 (1.9%)
Other 148 (1.6%)
22 (0.2%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 7,107 (61.0%)
R 1,301 (11.2%)
Hospitalization 1,154 (9.9%)
Death 781 (6.7%)
H 547 (4.7%)
L 289 (2.5%)
212 (1.8%)
Life Threatening 157 (1.3%)
Other 49 (0.4%)
S 17 (0.1%)
O 16 (0.1%)
D 8 (0.1%)
Congenital Anomaly 8 (0.1%)
Disability 2 (0.0%)
Invalid Data 1 (0.0%)

Top Product Problems

Insufficient Information 2,204
Adverse Event Without Identified Device or Use Problem 961
Patient Device Interaction Problem 335
Intravalvular regurgitation 182
Inadequacy of Device Shape and/or Size 173
Appropriate Term/Code Not Available 100
Device Operates Differently Than Expected 53
Material Separation 53
Gradient Increase 48
Lack of Effect 44
Incomplete Coaptation 40
Perivalvular Leak 40
Backflow 30
Device Stenosis 27
Patient-Device Incompatibility 26
Detachment of Device or Device Component 24
Fluid/Blood Leak 21
No Apparent Adverse Event 21
Break 20
Leak/Splash 20

Yearly Trend

94
1994: 2
96
1996: 47
97
1997: 105
98
1998: 130
99
1999: 174
00
2000: 191
01
2001: 195
02
2002: 154
03
2003: 84
04
2004: 124
05
2005: 295
06
2006: 286
07
2007: 261
08
2008: 1,288
09
2009: 973
10
2010: 630
11
2011: 321
12
2012: 90
13
2013: 97
14
2014: 73
15
2015: 145
16
2016: 347
17
2017: 379
18
2018: 378
19
2019: 349
20
2020: 340
21
2021: 423
22
2022: 372
23
2023: 324
24
2024: 407
25
2025: 425
26
2026: 62

Related Entities for Ring, Annuloplasty

Event Locations

HOSPITAL 4,889 (51.6%)
I 2,255 (23.8%)
2,160 (22.8%)
OTHER 135 (1.4%)
OPERATING ROOM 10 (0.1%)
NO INFORMATION 6 (0.1%)
HOME 5 (0.1%)
INVALID DATA 5 (0.1%)
UNKNOWN 5 (0.1%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)

Compare EDWARDS LIFESCIENCES vs MEDTRONIC HEART VALVES DIVISION →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Ring, Annuloplasty, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (9,471 here).

Similar death-typed counts

Nearest other device types by death-typed report count (777 here), distinct from the volume row.

Disclaimer: MAUDE figures for Ring, Annuloplasty 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 Ring, Annuloplasty; 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.