2026 data FDA MAUDE openFDA

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

#127 of 1000 · 22,972 reports · 2003–2026

  • BOOK 22,972 reports
  • RANK #127 of 1000
  • DEATH 1,414 death-typed
  • INJ 13,527 injury-typed
  • MALF 8,031 malfunction
  • SPAN 2003–2026
  • PEAK 2025: 2,875
  • PHOTO Stent, Coronary

Nearest event-volume peer: Stent, Coronary (294 report gap)

Mitral Valve Repair Devices sits #127 of 1000 among tracked device types with 22,972 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 →

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 6.2% corpus 1.5% · above corpus mean (+4.6 pp)
  • INJ 58.9% corpus 30.4% · above corpus mean (+28.4 pp)
  • MALF 35.0% corpus 64.5% · below corpus mean (-29.5 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 53% 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 22,972 MAUDE reports, ranked #127 of 1000.

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

Event Types

Injury 13,527 (58.9%)
Malfunction 8,031 (35.0%)
Death 1,414 (6.2%)

Patient Outcomes

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

7,886 (27.4%)
Required Intervention 6,209 (21.5%)
Other 4,000 (13.9%)
Hospitalization 3,323 (11.5%)
R 3,244 (11.3%)
Death 1,382 (4.8%)
H 1,006 (3.5%)
S 870 (3.0%)
O 613 (2.1%)
Disability 93 (0.3%)
D 82 (0.3%)
L 81 (0.3%)
Life Threatening 31 (0.1%)
Congenital Anomaly 2 (0.0%)

Top Product Problems

Incomplete Coaptation 5,590
Adverse Event Without Identified Device or Use Problem 4,421
Unintended Movement 3,024
Difficult to Open or Close 2,814
Difficult to Remove 1,410
Difficult or Delayed Positioning 1,406
Positioning Failure 1,004
Improper or Incorrect Procedure or Method 963
Entrapment of Device 805
Migration 791
Device Damaged by Another Device 776
Off-Label Use 750
Break 648
Mechanical Jam 564
Leak/Splash 486
Physical Resistance/Sticking 469
Difficult or Delayed Activation 367
Expulsion 350
Failure To Adhere Or Bond 346
Activation Failure 342

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: 2,875
26
2026: 426

Related Entities for Mitral Valve Repair Devices

Event Locations

12,120 (52.8%)
I 10,790 (47.0%)
HOSPITAL 45 (0.2%)
NO INFORMATION 16 (0.1%)
OTHER 1 (0.0%)

Compare ABBOTT MEDICAL vs ABBOTT VASCULAR →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Mitral Valve Repair Devices, 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 (22,972 here).

Similar death-typed counts

Nearest other device types by death-typed report count (1,414 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.