Devices › Tricuspid valve repair device, percutaneously delivered
Device brand name · Tricuspid valve repair device percutaneously delivered
TriClip G5 Delivery System: medical device reports filed with FDA
502 reports name it, 2025–2026. Manufacturer given most often on reports: Abbott Medical. Product code NPS.
- 502
- device reports naming the brand
- 0% of all MAUDE reports · about 465 a year
- 476
- reports, 12 months to August 2026
- 26 in the 12 months before
- 49%
- classified as malfunction
- 35% across the product code
- 0%
- classified as death, as reported
- 0 reports · not verified by FDA
502 medical device reports received by FDA name the brand "TriClip G5 Delivery System" (tricuspid valve repair device percutaneously delivered); the manufacturer given most often on reports is Abbott Medical; received from June 2025 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
476 reports arrived in the 12 months to August 2026, up 1731% from 26 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 (50.6%), malfunction (49%) and other (0.4%); 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 (38.4%), difficult to flush (13.7%) and difficult to open or close (13.3%). The patient problems coded most often are tricuspid valve insufficiency/ regurgitation, foreign body in patient and embolism/embolus. 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.
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 | 193 | 38.4% | 41% |
| Difficult to flush | 69 | 13.7% | 3.3% |
| Difficult to open or close | 67 | 13.3% | 10.7% |
| Unintended movement | 55 | 11% | 8.2% |
| Entrapment of device | 51 | 10.2% | 7.8% |
| Device damaged by another device | 29 | 5.8% | 7.1% |
| Difficult or delayed positioning | 28 | 5.6% | 7.7% |
| Positioning failure | 27 | 5.4% | 4.3% |
| Difficult to removethe device was hard to remove | 26 | 5.2% | 6.7% |
| Migrationthe device moved from where it was placed | 18 | 3.6% | 5.8% |
| Difficult or delayed activation | 15 | 3% | 2.8% |
| Improper or incorrect procedure or method | 13 | 2.6% | 2% |
| Leak/splashthe device leaked | 10 | 2% | 1.7% |
| Breakthe device broke | 6 | 1.2% | 2% |
| Deformation due to compressive stress | 6 | 1.2% | 0.3% |
| Expulsion | 6 | 1.2% | 1.7% |
| Physical resistance/sticking | 6 | 1.2% | 1.8% |
| Retraction problem | 4 | 0.8% | 0.6% |
| Premature activation | 3 | 0.6% | 0.6% |
| Air/gas in device | 2 | 0.4% | 0.2% |
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 | 85 | 16.9% |
| Foreign body in patientpart of a device left in the patient | 22 | 4.4% |
| Embolism/embolus | 7 | 1.4% |
| Mitral valve insufficiency/ regurgitation | 6 | 1.2% |
| Dyspneashortness of breath | 3 | 0.6% |
| Swelling/ edema | 3 | 0.6% |
| Tachycardiafast heart rate | 3 | 0.6% |
| Arrhythmia | 2 | 0.4% |
| Cardiac arrestthe heart stopped | 2 | 0.4% |
| Low blood pressure/ hypotension | 2 | 0.4% |
| Pericardial effusionfluid around the heart | 2 | 0.4% |
| Thrombosis/thrombus | 2 | 0.4% |
| Air embolism | 1 | 0.2% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | TriClip G5 Delivery System | Product code NPS | All MAUDE reports |
|---|---|---|---|
| Reports | 502 | 2,117 | 26,136,888 |
| Share of that pool | — | 23.7% | 0% |
| Classified as death, per 1,000 reports | 0 | 38 | 9 |
| Classified as injury | 50.6% | 61.1% | 36.2% |
| Classified as malfunction | 49% | 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 G4 System | 1,368 | 387 | 0.7% |
| 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 G5 Delivery System reports
How many FDA reports name TriClip G5 Delivery System?
502 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 476 in the latest 12 months.
What kinds of events are reported?
injury (50.6%), malfunction (49%) and other (0.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incomplete coaptation (38.4%), difficult to flush (13.7%), difficult to open or close (13.3%), unintended movement (11%) and entrapment of device (10.2%). 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 G5 Delivery 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.