Devices › Tricuspid valve repair device, percutaneously delivered
Device brand name · Tricuspid valve repair device percutaneously delivered
TriClip G4 System: medical device reports filed with FDA
1,368 reports name it, 2024–2026. Manufacturer given most often on reports: Abbott Medical. Product code NPS.
- 1,368
- device reports naming the brand
- 0% of all MAUDE reports · about 609 a year
- 387
- reports, 12 months to August 2026
- 794 in the 12 months before
- 33.8%
- classified as malfunction
- 35% across the product code
- 0.7%
- classified as death, as reported
- 10 reports · not verified by FDA
1,368 medical device reports received by FDA name the brand "TriClip G4 System" (tricuspid valve repair device percutaneously delivered); the manufacturer given most often on reports is Abbott Medical; received from April 2024 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
387 reports arrived in the 12 months to August 2026, down 51% from 794 in the 12 months before. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases. The event types recorded are injury (65.5%), malfunction (33.8%) and death (0.7%); across all tricuspid valve repair device, percutaneously delivered reports (product code NPS) death is recorded in 3.8% and malfunction in 35%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incomplete coaptation (45.3%), difficult to open or close (11.7%) and difficult or delayed positioning (9.6%). The patient problems coded most often are tricuspid valve insufficiency/ regurgitation, foreign body in patient and dyspnea. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Reports by month, five years
Reports by the month FDA received them. FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 2,117 reports carrying product code NPS. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share | Share across product code |
|---|---|---|---|
| Incomplete coaptation | 620 | 45.3% | 41% |
| Difficult to open or close | 160 | 11.7% | 10.7% |
| Difficult or delayed positioning | 131 | 9.6% | 7.7% |
| Device damaged by another device | 119 | 8.7% | 7.1% |
| Unintended movement | 117 | 8.6% | 8.2% |
| Difficult to removethe device was hard to remove | 116 | 8.5% | 6.7% |
| Entrapment of device | 114 | 8.3% | 7.8% |
| Migrationthe device moved from where it was placed | 96 | 7% | 5.8% |
| Positioning failure | 59 | 4.3% | 4.3% |
| Difficult or delayed activation | 45 | 3.3% | 2.8% |
| Breakthe device broke | 35 | 2.6% | 2% |
| Improper or incorrect procedure or method | 30 | 2.2% | 2% |
| Physical resistance/sticking | 27 | 2% | 1.8% |
| Expulsion | 25 | 1.8% | 1.7% |
| Leak/splashthe device leaked | 24 | 1.8% | 1.7% |
| Mechanical jam | 17 | 1.2% | 0.8% |
| Material deformation | 14 | 1% | 0.7% |
| Material split, cut or torn | 13 | 1% | 0.8% |
| Difficult to insertthe device was hard to insert | 9 | 0.7% | 0.4% |
| Noise, audible | 9 | 0.7% | 0.6% |
FDA's device problem codes as entered on the report; one report can carry several. Generic codes such as "no apparent adverse event" are left out.
Patient problems coded
| Patient problem (FDA code) | Reports | Share |
|---|---|---|
| Tricuspid valve insufficiency/ regurgitation | 362 | 26.5% |
| Foreign body in patientpart of a device left in the patient | 54 | 3.9% |
| Dyspneashortness of breath | 50 | 3.7% |
| Heart failure/congestive heart failure | 35 | 2.6% |
| Mitral valve insufficiency/ regurgitation | 29 | 2.1% |
| Swelling/ edema | 24 | 1.8% |
| Embolism/embolus | 20 | 1.5% |
| Fatiguetiredness | 16 | 1.2% |
| Low blood pressure/ hypotension | 6 | 0.4% |
| Arrhythmia | 5 | 0.4% |
| Pleural effusionfluid around the lung | 5 | 0.4% |
| Tachycardiafast heart rate | 5 | 0.4% |
| Tricuspid valve stenosis | 5 | 0.4% |
| Cardiac tamponade | 4 | 0.3% |
| Pericardial effusionfluid around the heart | 3 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | TriClip G4 System | Product code NPS | All MAUDE reports |
|---|---|---|---|
| Reports | 1,368 | 2,117 | 26,136,888 |
| Share of that pool | — | 64.6% | 0% |
| Classified as death, per 1,000 reports | 7 | 38 | 9 |
| Classified as injury | 65.5% | 61.1% | 36.2% |
| Classified as malfunction | 33.8% | 35% | 62.3% |
| Filed by the manufacturer | 100% | 99.8% | 94.9% |
Shares are of reports, not of devices in use. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data."
Other brands with product code NPS
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| TriClip G5 Delivery System | 502 | 476 | 0% |
| TriClip Delivery System (TCDS) | 240 | 118 | 29.6% |
Ordered by report count for navigation only. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA also states that "common products may have a higher number of adverse events due to the higher total number of people using the product."
Questions about TriClip G4 System reports
How many FDA reports name TriClip G4 System?
1,368 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 387 in the latest 12 months.
What kinds of events are reported?
injury (65.5%), malfunction (33.8%) and death (0.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incomplete coaptation (45.3%), difficult to open or close (11.7%), difficult or delayed positioning (9.6%), device damaged by another device (8.7%) and unintended movement (8.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (100%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that TriClip G4 System was at fault?
No. FDA states that "MDR data alone cannot be used to establish rates of events, evaluate a change in event rates over time or compare event rates between devices. The number of reports cannot be interpreted or used in isolation to reach conclusions about the existence, severity, or frequency of problems associated with devices." It adds that the reporting system "has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data." FDA adds that "a causal relationship cannot be established between product and reactions listed in a report."
How do I report a problem with a medical device?
Through FDA MedWatch (Form FDA 3500 for health professionals and consumers), or to the manufacturer. See the guide on how to report.
Where this comes from. Counts are built from the openFDA Device Adverse Event (MAUDE) bulk export released 28 Sep 2026, which holds reports FDA received through 31 Aug 2026. Brand, generic and manufacturer names are as written on the reports; product code names come from FDA's device classification. A report counts here when any device it lists carries this brand name after punctuation and capitalisation are normalised. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.
Drug data (FAERS) through 30 Jun 2026; device data (MAUDE) through 31 Aug 2026. Not medical advice.