Device brand name · Ring annuloplasty
Simulus Fully Flexible Annuloplasty Band: medical device reports filed with FDA
228 reports name it, 2015–2026. Manufacturer given most often on reports: Medtronic Heart Valves Division. Product code KRH.
- 228
- device reports naming the brand
- 0% of all MAUDE reports · about 20 a year
- 13
- reports, 12 months to August 2026
- 12 in the 12 months before
- 0%
- classified as malfunction
- 2.2% across the product code
- 0.9%
- classified as death, as reported
- 2 reports · not verified by FDA
FDA's MAUDE database holds 228 reports that name the brand "Simulus Fully Flexible Annuloplasty Band" (ring annuloplasty), received between February 2015 and July 2026; the manufacturer given most often on reports is Medtronic Heart Valves Division. Spellings of one product vary from report to report.
13 reports arrived in the 12 months to August 2026, close to the 12 of 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 (99.1%) and death (0.9%); across all ring, annuloplasty reports (product code KRH) death is recorded in 8.1% and malfunction in 2.2%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (59.2%), inadequacy of device shape and/or size (7.9%) and patient device interaction problem (2.6%). The patient problems coded most often are mitral regurgitation, mitral valve insufficiency/ regurgitation and endocarditis. 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 9,698 reports carrying product code KRH. 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 |
|---|---|---|---|
| Insufficient device problem information | 135 | 59.2% | 25.4% |
| Inadequacy of device shape and/or size | 18 | 7.9% | 2.3% |
| Patient device interaction problem | 6 | 2.6% | 4% |
| Material separation | 3 | 1.3% | 0.6% |
| Device operates differently than expectedthe device behaved unexpectedly | 2 | 0.9% | 0.7% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 0.9% | 0.3% |
| Perivalvular leak | 2 | 0.9% | 1.3% |
| Breakthe device broke | 1 | 0.4% | 0.3% |
| Calcified | 1 | 0.4% | 0.3% |
| Incomplete coaptation | 1 | 0.4% | 0.6% |
| Intravalvular regurgitation | 1 | 0.4% | 2.6% |
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 | 51 | 22.4% |
| Mitral valve insufficiency/ regurgitation | 15 | 6.6% |
| Endocarditis | 4 | 1.8% |
| Calcium deposits/calcification | 3 | 1.3% |
| Non specific ekg/ECG changes | 3 | 1.3% |
| Tachycardiafast heart rate | 3 | 1.3% |
| Dyspneashortness of breath | 2 | 0.9% |
| Mitral insufficiency | 2 | 0.9% |
| Stroke/cva | 2 | 0.9% |
| Aneurysm | 1 | 0.4% |
| Arrhythmia | 1 | 0.4% |
| Atrial fibrillationan irregular heart rhythm | 1 | 0.4% |
| Atrial flutter | 1 | 0.4% |
| Cardiomyopathydisease of the heart muscle | 1 | 0.4% |
| Complete heart block | 1 | 0.4% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Simulus Fully Flexible Annuloplasty Band | Product code KRH | All MAUDE reports |
|---|---|---|---|
| Reports | 228 | 9,698 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 9 | 81 | 9 |
| Classified as injury | 99.1% | 88% | 36.2% |
| Classified as malfunction | 0% | 2.2% | 62.3% |
| Filed by the manufacturer | 100% | 98.7% | 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 KRH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Carpentier-Edwards Physio Annuloplasty Ring | 1,518 | 0 | 7.8% |
| Cosgrove-Edwards Annuloplasty System | 1,129 | 2 | 6.6% |
| CG Future Band | 1,064 | 131 | 1.1% |
| Carpentier-Edwards Classic Annuloplasty Ring | 813 | 0 | 10% |
| Edwards Mc3 Tricuspid Annuloplasty System | 385 | 0 | 50.4% |
| Simulus Semi-Rigid Annulopasty Ring | 235 | 13 | 0.4% |
| Cosgrove-Edwards Annuloplasty System With Duraflo Treatment | 222 | 0 | 9.9% |
| Carpentier-Edwards Physio Annuloplasty Ring With Duraflo Treatment | 167 | 0 | 23.4% |
| Simuplus | 164 | 49 | 1.2% |
| Carpentier-Edwards PERIMOUNT Plus Pericardial Bioprosthesis | 2,878 | 18 | 8.7% |
| Carpentier-Edwards Perimount Magna Aortic Bioprosthesis | 1,324 | 11 | 27.1% |
| Carpentier-Edwards Perimount Pericardial Bioprosthesis | 978 | 1 | 10% |
| Carpentier-Edwards Perimount Rsr Pericardial Bioprosthesis | 3,288 | 13 | 3.3% |
| Carpentier-Edwards Bioprosthesis | 1,055 | 3 | 5% |
| Carpentier-Edwards Perimount Aortic Pericardial Bioprosthesis | 864 | 7 | 7.1% |
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 Simulus Fully Flexible Annuloplasty Band reports
How many FDA reports name Simulus Fully Flexible Annuloplasty Band?
228 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 13 in the latest 12 months.
What kinds of events are reported?
injury (99.1%) and death (0.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (59.2%), inadequacy of device shape and/or size (7.9%), patient device interaction problem (2.6%), material separation (1.3%) and device operates differently than expected (0.9%). 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 Simulus Fully Flexible Annuloplasty Band 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.