Replacement heart-valve: medical device reports filed with FDA

37,240 reports carry this product code, 1992–2026; 30 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.

37,240
reports with this product code: 0.1% of all MAUDE reports; 1,916
reports, 12 months to August 2026: 3,492 in the 12 months before; 3.5%
classified as malfunction: 62.3% across all reports; 3.6%
classified as death, as reported: 0.9% across all reports

Product code DYE is FDA's classification for "Replacement heart-valve" (cardiovascular panel), a class 3 device. 37,240 medical device reports carry this product code, 0.1% of the MAUDE database, from January 1992 to August 2026.

1,916 reports arrived in the 12 months to August 2026, down 45% from 3,492 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 (92.7%), death (3.6%) and malfunction (3.5%). 30 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
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis	8,189	495	2.6%	2.1%
Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis	3,902	233	1%	1.4%
Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis	3,488	53	7.7%	2.9%
Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis	2,604	13	3.3%	1.8%
Mosaic Aortic Bioprosthetic Heart Valve	2,113	405	2.8%	8.4%
Carpentier-Edwards PERIMOUNT Plus Pericardial Bioprosthesis	2,093	18	8.7%	1.8%
Mosaic	1,924	131	0.5%	3%
Carpentier-Edwards Perimount Theon Pericardial Bioprosthesis	1,641	46	3.9%	3%
Carpentier-Edwards Perimount Aortic Pericardial Bioprosthesis	861	7	7.1%	3.2%
Carpentier-Edwards Perimount Magna Mitral Ease Pericardial Bioprostheses	823	0	3.8%	4.9%
Carpentier-Edwards Perimount Magna Mitral Pericardial Bioprosthesis	794	1	12.9%	4.5%
Mosaic Mitral Bioprosthetic Heart Valve	750	154	6.4%	7.2%
Ni	646	1,587	1.8%	29.5%
Carpentier-Edwards Perimount Magna Aortic Bioprosthesis	601	11	27.1%	1.8%
Carpentier-Edwards Bioprosthesis	234	3	5%	0.6%
Mosaic Porcine Heart Valve	202	11	0.6%	0.6%
Carpentier-Edwards PERIMOUNT Magna Ease Pericardial aortic Bioprosthesis	188	32	31.4%	0%
Carpentier-Edwards Perimount Pericardial Aortic Bioprosthesis	167	7	1.2%	3%
Mitroflow Aortic Pericardial Heart Valve	167	0	16.8%	1.8%
Carpentier-Edwards Perimount Pericardial Bioprosthesis	142	1	10%	0.6%
Edwards Prima Plus Stentless Bioprosthesis	110	0	2.6%	2%
Hancock	103	22	1.5%	1.7%
Perceval Sutureless Aortic Heart Valve	66	18	9.1%	2.3%
Edwards INSPIRIS RESILIA Aortic Valve	33	599	0.8%	0.9%
EDWARDS INTUITY ELITE Valve System	26	62	2.2%	1.6%
Asku	22	210	1.1%	47.1%
INSPIRIS RESILIA Aortic Valve	22	87	0.4%	5.6%
Carpentier-Edwards Physio Annuloplasty Ring	17	0	7.8%	0.5%
Medtronic Hall Prosthetic Heart Valve	16	0	19.8%	32.4%
Avalus Aortic Tissue Valve	13	133	11%	16.4%

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
Edwards Lifesciences	30,436	81.7%
Medtronic Heart Valves Division	5,611	15.1%
Medtronic Heart Valve Division	351	0.9%
Livanova Canada	137	0.4%
Medtronic Heart Valves	92	0.2%
Medtronic Mexico	42	0.1%
Heart Valves Santa Ana	23	0.1%
Sorin Group Italia	14	0%
Guidant Vascular Intervention	4	0%
Medtronic	4	0%
St Jude Medical	3	0%
Cryolife	2	0%
Alcon Research /Huntington	1	0%
Bard Access Systems	1	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

Death3.6%1,342

Injury92.7%34,505

Malfunction3.5%1,310

Other0%9

Not given0.2%74

Who filed

Manufacturer report99.2%36,951

Voluntary report0.5%182

User facility report0%0

Distributor report0%0

Not given0.3%107

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

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	14,464	38.8%
Gradient increase	6,150	16.5%
Calcified	5,241	14.1%
Degraded	4,771	12.8%
Device stenosis	2,645	7.1%
Fluid/blood leak	2,445	6.6%
Incomplete coaptation	1,747	4.7%
Perivalvular leak	1,574	4.2%
Patient device interaction problem	1,315	3.5%
Intravalvular regurgitation	1,193	3.2%
Difficult to open or close	606	1.6%
Inadequacy of device shape and/or size	379	1%
Structural problem	307	0.8%
Material split, cut or torn	278	0.7%
Deterioration of prosthesis	212	0.6%
Leak/splashthe device leaked	182	0.5%
Patient-device incompatibilitythe device did not suit the patient	182	0.5%
Thickening of material	137	0.4%
Torn material	114	0.3%
Breakthe device broke	104	0.3%

Questions about replacement heart-valve reports

What is product code DYE?

FDA's classification code for "Replacement heart-valve", class 3, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

37,240 reports through August 2026, 1,916 of them in the latest 12 months.

Which brands appear most often?

Carpentier-Edwards PERIMOUNT Magna Ease Pericardial Bioprosthesis (8,189), Carpentier-Edwards PERIMOUNT Magna Mitral Ease Pericardial Bioprosthesis (3,902), Carpentier-Edwards Perimount Magna Pericardial Bioprosthesis (3,488), Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis (2,604) and Mosaic Aortic Bioprosthetic Heart Valve (2,113). 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.