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2026 data FDA MAUDE openFDA

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.

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FDA MAUDE casebook

openFDA event book Tricuspid Valve Repair Device LIGHT-BOOK · MAUDE

#538 of 1000 · 1,605 reports · 2022–2026

  • BOOK 1,605 reports
  • RANK #538 of 1000
  • DEATH 61 death-typed
  • INJ 971 injury-typed
  • MALF 573 malfunction
  • SPAN 2022–2026
  • PEAK 2025: 930
  • PHOTO Assay

Nearest event-volume peer: Assay, Enzyme Linked Immunosorbent, Hepatitis C Virus (6 report gap)

Tricuspid Valve Repair Device, Percutaneously Delivered sits #538 of 1000 among tracked device types with 1,605 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 →

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 3.8% corpus 1.5% · above corpus mean (+2.3 pp)
  • INJ 60.5% corpus 30.4% · above corpus mean (+30.1 pp)
  • MALF 35.7% corpus 64.5% · below corpus mean (-28.8 pp)

Lead product-problem code Incomplete Coaptation is 31% of coded problems · Lead manufacturer ABBOTT MEDICAL accounts for 90% 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 1,605 MAUDE reports, ranked #538 of 1000.

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

Event Types

Injury 971 (60.5%)
Malfunction 573 (35.7%)
Death 61 (3.8%)

Patient Outcomes

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

Required Intervention 573 (30.1%)
524 (27.5%)
Other 315 (16.6%)
R 118 (6.2%)
Hospitalization 115 (6.0%)
H 100 (5.3%)
O 78 (4.1%)
Death 60 (3.2%)
D 12 (0.6%)
S 3 (0.2%)
L 2 (0.1%)
Disability 2 (0.1%)
Life Threatening 1 (0.1%)

Top Product Problems

Incomplete Coaptation 666
Adverse Event Without Identified Device or Use Problem 200
Difficult to Open or Close 171
Difficult or Delayed Positioning 133
Device Damaged by Another Device 125
Entrapment of Device 122
Unintended Movement 120
Difficult to Remove 107
Migration 97
Difficult to Flush 68
Positioning Failure 65
Difficult or Delayed Activation 46
Break 33
Improper or Incorrect Procedure or Method 33
Physical Resistance/Sticking 32
Leak/Splash 28
Expulsion 24
Mechanical Jam 17
Material Deformation 15
Material Split, Cut or Torn 14

Yearly Trend

22
2022: 1
24
2024: 546
25
2025: 930
26
2026: 128

Related Entities for Tricuspid Valve Repair Device, Percutaneously Delivered

Top Manufacturers

ABBOTT MEDICAL 1,442
ABBOTT VASCULAR INC. 160
ABBOTT VASCULAR 1

Event Locations

1,604 (99.9%)
HOSPITAL 1 (0.1%)

Compare ABBOTT MEDICAL vs ABBOTT VASCULAR INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Tricuspid Valve Repair Device, 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 (1,605 here).

Assay 1,611 Endoscopic Guidewire 1,598 Microfilter, Blood Transfusion 1,615 Retractor 1,615

Similar death-typed counts

Nearest other device types by death-typed report count (61 here), distinct from the volume row.

Dressing, Wound, Drug 61 Drug-Eluting Percutaneous Transluminal Coro… 61 Appliance 59 Colonoscope And Accessories, Flexible/Rigid 63

Read our methodology - how this data is sourced, computed, and verified.

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.