2026 data FDA MAUDE openFDA FDA Class III

Mitral Valve Repair Devices

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 Mitral Valve Repair Devices MID-BOOK · MAUDE

#124 of 1000 · 25,400 reports · 2003–2026

  • BOOK 25,400 reports
  • RANK #124 of 1000
  • DEATH 1,771 death-typed
  • INJ 15,080 injury-typed
  • MALF 8,549 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 2,874
  • PHOTO Shunt

Nearest event-volume peer: Shunt, Central Nervous System And Components (18 report gap)

Mitral Valve Repair Devices sits #124 of 1000 among tracked device types with 25,400 MAUDE reports spanning 2003–2026. 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

Mitral Valve Repair Devices carries 33.7% MALFUNCTION-coded reports, 31.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 7.0% corpus 1.5% · above corpus mean (+5.5 pp)
  • INJ 59.4% corpus 30.3% · above corpus mean (+29.1 pp)
  • MALF 33.7% corpus 64.8% · below corpus mean (-31.2 pp)

Lead product-problem code Incomplete Coaptation is 20% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 38% of manufacturer-tagged reports · Top event location is 57% of location-tagged rows .

Mitral Valve Repair Devices in the event-volume neighbourhood

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

reports

What this shows Mitral Valve Repair Devices carries 25,400 MAUDE reports, ranked #124 of 1000.

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

Event Types

Injury 15,080 (59.4%)
Malfunction 8,549 (33.7%)
Death 1,771 (7.0%)

Patient Outcomes

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

8,366 (26.6%)
Required Intervention 7,343 (23.3%)
Other 4,387 (13.9%)
Hospitalization 3,390 (10.8%)
R 3,344 (10.6%)
Death 1,639 (5.2%)
H 1,119 (3.6%)
S 873 (2.8%)
O 729 (2.3%)
Disability 96 (0.3%)
D 90 (0.3%)
L 82 (0.3%)
Life Threatening 31 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Incomplete Coaptation 6,168
Adverse Event Without Identified Device or Use Problem 4,800
Unintended Movement 3,316
Difficult to Open or Close 3,094
Difficult to Remove 1,651
Difficult or Delayed Positioning 1,501
Insufficient Device Problem Information 1,130
Positioning Failure 1,110
Improper or Incorrect Procedure or Method 1,034
Entrapment of Device 883
Migration 855
Device Damaged by Another Device 844
Off-Label Use 769
Break 720
Mechanical Jam 644
Leak/Splash 527
Failure To Adhere Or Bond 522
Physical Resistance/Sticking 505
Difficult To Position 426
Activation Failure 420

Yearly Trend

03
2003: 1
12
2012: 1
13
2013: 40
14
2014: 484
15
2015: 544
16
2016: 826
17
2017: 1,138
18
2018: 1,668
19
2019: 2,278
20
2020: 2,724
21
2021: 2,346
22
2022: 2,584
23
2023: 2,475
24
2024: 2,562
25
2025: 2,874
26
2026: 2,855

Reports in 2025 (2,874) held close to the prior two-year average of 2,519.

Related Entities for Mitral Valve Repair Devices

Event Locations

14,545 (57.3%)
I 10,789 (42.5%)
HOSPITAL 49 (0.2%)
NO INFORMATION 16 (0.1%)
OTHER 1 (0.0%)

Compare ABBOTT MEDICAL vs ABBOTT VASCULAR →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Mitral Valve Repair Devices: 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 (25,400 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,771 here), distinct from the volume row.

Disclaimer: MAUDE figures for Mitral Valve Repair Devices 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 Mitral Valve Repair Devices; 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.