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Device brand name · Mitraclip delivery system
Mitraclip Xtr Delivery System: medical device reports filed with FDA
1,050 reports name it, 2018–2020. Manufacturer given most often on reports: Av-Temecula-Ct. Product code NKM.
- 1,050
- device reports naming the brand
- 0% of all MAUDE reports · about 126 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 37.3%
- classified as malfunction
- 33.6% across the product code
- 4.8%
- classified as death, as reported
- 50 reports · not verified by FDA
1,050 medical device reports received by FDA name the brand "Mitraclip Xtr Delivery System" (mitraclip delivery system); the manufacturer given most often on reports is Av-Temecula-Ct; received from March 2018 to June 2020. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (57.9%), malfunction (37.3%) and death (4.8%); 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 (29%), unintended movement (16.8%) and difficult to open or close (15.1%). The patient problems coded most often are mitral regurgitation, tissue damage and no patient involvement. 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
No report naming Mitraclip Xtr Delivery System was received in the five years to August 2026; the latest was received in June 2020.
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 | 304 | 29% | 24.2% |
| Unintended movement | 176 | 16.8% | 13.1% |
| Difficult to open or close | 159 | 15.1% | 12.2% |
| Off-label use | 120 | 11.4% | 3% |
| Improper or incorrect procedure or method | 78 | 7.4% | 4% |
| Difficult to removethe device was hard to remove | 74 | 7% | 6.5% |
| Difficult or delayed positioning | 72 | 6.9% | 5.9% |
| Migrationthe device moved from where it was placed | 64 | 6.1% | 3.4% |
| Device damaged by another device | 57 | 5.4% | 3.3% |
| Breakthe device broke | 48 | 4.6% | 2.8% |
| Positioning failure | 39 | 3.7% | 4.4% |
| Physical resistance/sticking | 36 | 3.4% | 2% |
| Expulsion | 32 | 3% | 1.4% |
| Difficult or delayed activation | 25 | 2.4% | 1.5% |
| Mechanical jam | 23 | 2.2% | 2.5% |
| Entrapment of device | 22 | 2.1% | 3.5% |
| Leak/splashthe device leaked | 17 | 1.6% | 2.1% |
| Mechanical problema mechanical problem | 14 | 1.3% | 0.5% |
| Material separation | 12 | 1.1% | 0.9% |
| Retraction problem | 12 | 1.1% | 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 regurgitation | 220 | 21% |
| Tissue damage | 206 | 19.6% |
| No patient involvement | 63 | 6% |
| Foreign body in patientpart of a device left in the patient | 38 | 3.6% |
| Dyspneashortness of breath | 35 | 3.3% |
| Heart failure | 30 | 2.9% |
| Tricuspid regurgitation | 30 | 2.9% |
| Embolism | 25 | 2.4% |
| Mitral valve stenosis | 24 | 2.3% |
| Low blood pressure/ hypotension | 23 | 2.2% |
| Stroke/cva | 14 | 1.3% |
| Thrombosis | 14 | 1.3% |
| Deaththe patient died; cause not stated by this term | 13 | 1.2% |
| Pericardial effusionfluid around the heart | 13 | 1.2% |
| Atrial perforation | 10 | 1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Mitraclip Xtr Delivery System | Product code NKM | All MAUDE reports |
|---|---|---|---|
| Reports | 1,050 | 25,635 | 26,136,888 |
| Share of that pool | — | 4.1% | 0% |
| Classified as death, per 1,000 reports | 48 | 70 | 9 |
| Classified as injury | 57.9% | 59.4% | 36.2% |
| Classified as malfunction | 37.3% | 33.6% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| MitraClip G4 Clip Delivery System (MDR) | 2,065 | 209 | 2.1% |
| 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 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 Xtr Delivery System reports
How many FDA reports name Mitraclip Xtr Delivery System?
1,050 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (57.9%), malfunction (37.3%) and death (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
incomplete coaptation (29%), unintended movement (16.8%), difficult to open or close (15.1%), off-label use (11.4%) and improper or incorrect procedure or method (7.4%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Mitraclip Xtr 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.