2026 data FDA MAUDE openFDA FDA Class III

Tricuspid Valve Repair Device, 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 Tricuspid Valve Repair Device LIGHT-BOOK · MAUDE

#498 of 1000 · 2,028 reports · 2022–2026

  • BOOK 2,028 reports
  • RANK #498 of 1000
  • DEATH 77 death-typed
  • INJ 1,234 injury-typed
  • MALF 717 malfunction
  • SPAN 2022–2026
  • PEAK 2025: 931
  • PHOTO Apparatus

Nearest event-volume peer: Apparatus, Suction, Ward Use, Portable, Ac-Powered (2 report gap)

Tricuspid Valve Repair Device, Percutaneously Delivered sits #498 of 1000 among tracked device types with 2,028 MAUDE reports spanning 2022–2026. 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 →

Injury-coded reports run above the device-type norm

Tricuspid Valve Repair Device carries 60.8% INJURY-coded reports, 30.6pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 3.8% corpus 1.5% · above corpus mean (+2.3 pp)
  • INJ 60.8% corpus 30.3% · above corpus mean (+30.6 pp)
  • MALF 35.4% corpus 64.8% · below corpus mean (-29.5 pp)

Lead product-problem code Incomplete Coaptation is 31% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 92% of manufacturer-tagged reports · Top event location is 100% of location-tagged rows .

Tricuspid Valve Repair Device in the event-volume neighbourhood

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

reports

What this shows Tricuspid Valve Repair Device, Percutaneously Delivered carries 2,028 MAUDE reports, ranked #498 of 1000.

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

Event Types

Injury 1,234 (60.8%)
Malfunction 717 (35.4%)
Death 77 (3.8%)

Patient Outcomes

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

Required Intervention 711 (30.3%)
645 (27.5%)
Other 403 (17.2%)
Hospitalization 135 (5.8%)
R 134 (5.7%)
H 122 (5.2%)
O 97 (4.1%)
Death 75 (3.2%)
D 12 (0.5%)
S 5 (0.2%)
L 2 (0.1%)
Disability 2 (0.1%)
Life Threatening 1 (0.0%)

Top Product Problems

Incomplete Coaptation 832
Adverse Event Without Identified Device or Use Problem 257
Difficult to Open or Close 220
Unintended Movement 163
Difficult or Delayed Positioning 161
Entrapment of Device 158
Device Damaged by Another Device 145
Difficult to Remove 137
Migration 117
Positioning Failure 88
Difficult to Flush 69
Difficult or Delayed Activation 58
Improper or Incorrect Procedure or Method 42
Break 40
Physical Resistance/Sticking 38
Expulsion 35
Leak/Splash 34
Mechanical Jam 18
Material Deformation 16
Material Split, Cut or Torn 16

Yearly Trend

22
2022: 1
24
2024: 546
25
2025: 931
26
2026: 550

Reports rose to 931 in 2025, up from an average of 274 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Tricuspid Valve Repair Device, Percutaneously Delivered

Event Locations

2,027 (100.0%)
HOSPITAL 1 (0.0%)

Compare ABBOTT MEDICAL vs ABBOTT VASCULAR INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Tricuspid Valve Repair Device: 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 (2,028 here).

Similar death-typed counts

Nearest other device types by death-typed report count (77 here), distinct from the volume row.

Disclaimer: MAUDE figures for Tricuspid Valve Repair Device 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 Tricuspid Valve Repair Device; 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.