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Device brand name · Mitral valve repair devices
MitraClip G4 Clip Delivery System (MDR): medical device reports filed with FDA
2,065 reports name it, 2023–2026. Manufacturer given most often on reports: Abbott Medical. Product code NKM.
- 2,065
- device reports naming the brand
- 0% of all MAUDE reports · about 606 a year
- 209
- reports, 12 months to August 2026
- 716 in the 12 months before
- 41%
- classified as malfunction
- 33.6% across the product code
- 2.1%
- classified as death, as reported
- 44 reports · not verified by FDA
2,065 medical device reports received by FDA name the brand "MitraClip G4 Clip Delivery System (MDR)" (mitral valve repair devices); the manufacturer given most often on reports is Abbott Medical; received from February 2023 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
209 reports arrived in the 12 months to August 2026, down 71% from 716 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 (56.9%), malfunction (41%) and death (2.1%); across all mitral valve repair devices reports (product code NKM) death is recorded in 7% and malfunction in 33.6%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are incomplete coaptation (28.5%), unintended movement (21.2%) and difficult to open or close (19.2%). The patient problems coded most often are mitral valve insufficiency/ regurgitation, dyspnea and foreign body in patient. 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 25,635 reports carrying product code NKM. 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 | 589 | 28.5% | 24.2% |
| Unintended movement | 437 | 21.2% | 13.1% |
| Difficult to open or close | 396 | 19.2% | 12.2% |
| Difficult or delayed positioning | 165 | 8% | 5.9% |
| Positioning failure | 137 | 6.6% | 4.4% |
| Difficult to removethe device was hard to remove | 126 | 6.1% | 6.5% |
| Entrapment of device | 104 | 5% | 3.5% |
| Device damaged by another device | 97 | 4.7% | 3.3% |
| Improper or incorrect procedure or method | 81 | 3.9% | 4% |
| Breakthe device broke | 72 | 3.5% | 2.8% |
| Off-label use | 66 | 3.2% | 3% |
| Migrationthe device moved from where it was placed | 61 | 3% | 3.4% |
| Physical resistance/sticking | 43 | 2.1% | 2% |
| Difficult or delayed activation | 42 | 2% | 1.5% |
| Expulsion | 36 | 1.7% | 1.4% |
| Leak/splashthe device leaked | 30 | 1.5% | 2.1% |
| Material deformation | 28 | 1.4% | 0.8% |
| Mechanical jam | 25 | 1.2% | 2.5% |
| Material split, cut or torn | 17 | 0.8% | 0.5% |
| Premature activation | 17 | 0.8% | 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 |
|---|---|---|
| Mitral valve insufficiency/ regurgitation | 453 | 21.9% |
| Dyspneashortness of breath | 78 | 3.8% |
| Foreign body in patientpart of a device left in the patient | 54 | 2.6% |
| Mitral valve stenosis | 35 | 1.7% |
| Embolism/embolus | 34 | 1.6% |
| Pericardial effusionfluid around the heart | 30 | 1.5% |
| Low blood pressure/ hypotension | 29 | 1.4% |
| Heart failure/congestive heart failure | 26 | 1.3% |
| Thrombosis/thrombus | 24 | 1.2% |
| Tricuspid valve insufficiency/ regurgitation | 16 | 0.8% |
| Stroke/cva | 10 | 0.5% |
| Cardiogenic shockshock from the heart failing to pump | 9 | 0.4% |
| Tachycardiafast heart rate | 8 | 0.4% |
| Cardiac arrestthe heart stopped | 7 | 0.3% |
| Perforation | 7 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | MitraClip G4 Clip Delivery System (MDR) | Product code NKM | All MAUDE reports |
|---|---|---|---|
| Reports | 2,065 | 25,635 | 26,136,888 |
| Share of that pool | — | 8.1% | 0% |
| Classified as death, per 1,000 reports | 21 | 70 | 9 |
| Classified as injury | 56.9% | 59.4% | 36.2% |
| Classified as malfunction | 41% | 33.6% | 62.3% |
| Filed by the manufacturer | 100% | 99.7% | 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 NKM
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| MITRACLIP SYSTEM Clip Delivery System | 5,445 | 299 | 14.9% |
| Mitraclip G4 Clip Delivery System | 5,216 | 0 | 2.3% |
| Mitraclip | 3,357 | 1,161 | 2% |
| Mitraclip System Clip Delivery System Nt | 2,309 | 0 | 4.6% |
| Edwards Pascal Precision | 1,909 | 1,395 | 16.4% |
| MitraClip G5 Delivery System | 1,408 | 1,335 | 1.4% |
| Mitraclip G4 Clip Delivery System Mdd | 1,193 | 0 | 3.2% |
| Mitraclip Xtr Delivery System | 1,050 | 0 | 4.8% |
| Mitraclip Xtr Clip Delivery System | 699 | 0 | 3.3% |
| Mitraclip Ntr Delivery System | 571 | 0 | 2.6% |
| Mitraclip Ntr Clip Delivery System | 455 | 0 | 4.4% |
| Mitraclip Clip Delivery System | 338 | 0 | 38.5% |
| Abbott | 265 | 0 | 7.5% |
| MitraClip G5 Steerable Guide Catheter | 368 | 363 | 0.5% |
| Mitraclip System Steerable Guide Catheter | 1,528 | 16 | 3% |
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 MitraClip G4 Clip Delivery System (MDR) reports
How many FDA reports name MitraClip G4 Clip Delivery System (MDR)?
2,065 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 209 in the latest 12 months.
What kinds of events are reported?
injury (56.9%), malfunction (41%) and death (2.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incomplete coaptation (28.5%), unintended movement (21.2%), difficult to open or close (19.2%), difficult or delayed positioning (8%) and positioning failure (6.6%). 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 MitraClip G4 Clip Delivery System (MDR) 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.