Device brand name · Stent coronary
Omega: medical device reports filed with FDA
353 reports name it, 2011–2017. Manufacturer given most often on reports: Boston Scientific - Maple Grove. Product code MAF.
- 353
- device reports naming the brand
- 0% of all MAUDE reports · about 24 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 85.3%
- classified as malfunction
- 40.4% across the product code
- 1.4%
- classified as death, as reported
- 5 reports · not verified by FDA
353 medical device reports received by FDA name the brand "Omega" (stent coronary); the manufacturer given most often on reports is Boston Scientific - Maple Grove; received from September 2011 to September 2017. 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 malfunction (85.3%), injury (13.3%) and death (1.4%); across all stent, coronary reports (product code MAF) death is recorded in 7.6% and malfunction in 40.4%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are bent (55%), failure to advance (27.8%) and device dislodged or dislocated (11.9%). The patient problems coded most often are no patient involvement, death and intimal dissection. 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 Omega was received in the five years to August 2026; the latest was received in September 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 23,279 reports carrying product code MAF. 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 |
|---|---|---|---|
| Bent | 194 | 55% | 3.6% |
| Failure to advance | 98 | 27.8% | 20.9% |
| Device dislodged or dislocated | 42 | 11.9% | 7% |
| Device damaged prior to usethe device was damaged before use | 31 | 8.8% | 3.8% |
| Breakthe device broke | 24 | 6.8% | 2.2% |
| Difficult to removethe device was hard to remove | 20 | 5.7% | 10.2% |
| Fracturea broken bone | 12 | 3.4% | 1% |
| Device damaged by another device | 10 | 2.8% | 0.3% |
| Difficult to advance | 9 | 2.5% | 0.7% |
| Kinkedthe tube or line kinked | 7 | 2% | 1.1% |
| Material rupture | 6 | 1.7% | 0.8% |
| Occlusion within devicethe device blocked | 6 | 1.7% | 4.7% |
| Physical resistance | 4 | 1.1% | 2% |
| Activation, positioning or separation problem | 3 | 0.8% | 0.3% |
| Deflation problem | 3 | 0.8% | 2.2% |
| Detachment of device component | 3 | 0.8% | 3.3% |
| Difficult to insertthe device was hard to insert | 3 | 0.8% | 6.7% |
| Inflation problem | 3 | 0.8% | 2.5% |
| Entrapment of device | 2 | 0.6% | 0.6% |
| Malposition of device | 2 | 0.6% | 0.1% |
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 |
|---|---|---|
| No patient involvement | 60 | 17% |
| Deaththe patient died; cause not stated by this term | 5 | 1.4% |
| Intimal dissection | 5 | 1.4% |
| Thrombosis | 5 | 1.4% |
| Myocardial infarctionheart attack | 3 | 0.8% |
| Chest painchest pain | 2 | 0.6% |
| Device embedded in tissue or plaque | 2 | 0.6% |
| Ischemia | 2 | 0.6% |
| Low blood pressure/ hypotension | 2 | 0.6% |
| Reocclusion | 2 | 0.6% |
| St segment elevation | 2 | 0.6% |
| Thrombus | 2 | 0.6% |
| Angina | 1 | 0.3% |
| Bradycardiaslow heart rate | 1 | 0.3% |
| Cardiac enzyme elevation | 1 | 0.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Omega | Product code MAF | All MAUDE reports |
|---|---|---|---|
| Reports | 353 | 23,279 | 26,136,888 |
| Share of that pool | — | 1.5% | 0% |
| Classified as death, per 1,000 reports | 14 | 76 | 9 |
| Classified as injury | 13.3% | 51.3% | 36.2% |
| Classified as malfunction | 85.3% | 40.4% | 62.3% |
| Filed by the manufacturer | 100% | 95.6% | 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 MAF
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Graftmaster Rx Coronary Stent Graft System | 2,163 | 0 | 13.1% |
| Multi-Link Rx Vision Coronary Stent System | 1,875 | 0 | 4.2% |
| Jostent Graftmaster | 1,373 | 0 | 23.5% |
| Express2 Monorail Coronary Stent Delivery System | 881 | 0 | 2.5% |
| Multi-Link Mini Vision Rx Coronary Stent System | 867 | 0 | 4.7% |
| Liberte' Monorail Coronary Stent Delivery System | 802 | 0 | 3.4% |
| Multi-Link 8 | 621 | 1 | 1.6% |
| Rebel | 620 | 0 | 1.8% |
| Veriflex Liberte Coronary Stent Delivery System | 603 | 0 | 18.6% |
| Integrity Rx | 533 | 0 | 8.4% |
| Graftmaster | 568 | 131 | 9.9% |
| Libert | 415 | 0 | 0.7% |
| Multi-Link Rx Zeta Coronary Stent System | 351 | 0 | 6.6% |
| Acs Rx Multi-Link Coronary Stent System | 327 | 6 | 6.1% |
| Multi-Link Rx Pixel Coronary Stent System | 326 | 0 | 4.3% |
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 Omega reports
How many FDA reports name Omega?
353 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?
malfunction (85.3%), injury (13.3%) and death (1.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
bent (55%), failure to advance (27.8%), device dislodged or dislocated (11.9%), device damaged prior to use (8.8%) and break (6.8%). 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 Omega 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.