Mitral valve repair devices: medical device reports filed with FDA

25,635 reports carry this product code, 2003–2026; 16 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

25,635
reports with this product code: 0.1% of all MAUDE reports; 4,203
reports, 12 months to August 2026: 2,618 in the 12 months before; 33.6%
classified as malfunction: 62.3% across all reports; 7%
classified as death, as reported: 0.9% across all reports

Product code NKM is FDA's classification for "Mitral valve repair devices" (unknown panel), a class 3 device. 25,635 medical device reports carry this product code, 0.1% of the MAUDE database, from December 2003 to August 2026.

4,203 reports arrived in the 12 months to August 2026, up 61% from 2,618 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 (59.4%), malfunction (33.6%) and death (7%). 16 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
MITRACLIP SYSTEM Clip Delivery System	5,444	299	14.9%	24.8%
Mitraclip G4 Clip Delivery System	5,216	0	2.3%	40.7%
Mitraclip	2,604	1,161	2%	42.5%
Mitraclip System Clip Delivery System Nt	2,309	0	4.6%	34.9%
MitraClip G4 Clip Delivery System (MDR)	2,065	209	2.1%	41%
Edwards Pascal Precision	1,908	1,395	16.4%	5.1%
MitraClip G5 Delivery System	1,408	1,335	1.4%	53.6%
Mitraclip G4 Clip Delivery System Mdd	1,193	0	3.2%	36.7%
Mitraclip Xtr Delivery System	1,050	0	4.8%	37.3%
Mitraclip Xtr Clip Delivery System	699	0	3.3%	30.5%
Mitraclip Ntr Delivery System	571	0	2.6%	41.2%
Mitraclip Ntr Clip Delivery System	455	0	4.4%	39.8%
Mitraclip Clip Delivery System	338	0	38.5%	8.3%
Abbott	1	0	7.5%	52.1%
MitraClip G5 Steerable Guide Catheter	1	363	0.5%	78%
Mitraclip System Steerable Guide Catheter	1	16	3%	43%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
Abbott Medical	10,020	39.1%
Abbott Vascular	7,623	29.7%
Av-Temecula-Ct	5,872	22.9%
Edwards Lifesciences	1,962	7.7%
St Jude Medical	3	0%

Reports by month, five years

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

Death7%1,786

Injury59.4%15,227

Malfunction33.6%8,622

Other0%0

Not given0%0

Who filed

Manufacturer report99.7%25,552

Voluntary report0.1%29

User facility report0%0

Distributor report0%0

Not given0.2%54

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Incomplete coaptation	6,206	24.2%
Unintended movement	3,352	13.1%
Difficult to open or close	3,130	12.2%
Difficult to removethe device was hard to remove	1,670	6.5%
Difficult or delayed positioning	1,509	5.9%
Insufficient device problem information	1,134	4.4%
Positioning failure	1,129	4.4%
Improper or incorrect procedure or method	1,037	4%
Entrapment of device	892	3.5%
Migrationthe device moved from where it was placed	859	3.4%
Device damaged by another device	857	3.3%
Off-label use	771	3%
Breakthe device broke	727	2.8%
Mechanical jam	647	2.5%
Leak/splashthe device leaked	531	2.1%
Failure to adhere or bond	522	2%
Physical resistance/sticking	506	2%
Activation failure	435	1.7%
Difficult to position	426	1.7%
Difficult or delayed activation	395	1.5%

Questions about mitral valve repair devices reports

What is product code NKM?

FDA's classification code for "Mitral valve repair devices", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

25,635 reports through August 2026, 4,203 of them in the latest 12 months.

Which brands appear most often?

MITRACLIP SYSTEM Clip Delivery System (5,444), Mitraclip G4 Clip Delivery System (5,216), Mitraclip (2,604), Mitraclip System Clip Delivery System Nt (2,309) and MitraClip G4 Clip Delivery System (MDR) (2,065). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.