Device brand name · Stent coronary
Integrity Rx: medical device reports filed with FDA
533 reports name it, 2011–2022. Manufacturer given most often on reports: Medtronic Ireland. Product code MAF.
- 533
- device reports naming the brand
- 0% of all MAUDE reports · about 36 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 54.2%
- classified as malfunction
- 40.4% across the product code
- 8.4%
- classified as death, as reported
- 45 reports · not verified by FDA
FDA's MAUDE database holds 533 reports that name the brand "Integrity Rx" (stent coronary), received between October 2011 and October 2022; the manufacturer given most often on reports is Medtronic Ireland. Spellings of one product vary from report to report.
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 (54.2%), injury (37.3%) and death (8.4%); 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 material deformation (27%), device dislodged or dislocated (21%) and device expiration issue (6.8%). The patient problems coded most often are death, myocardial infarction and reaction. 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 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 |
|---|---|---|---|
| Material deformation | 144 | 27% | 3% |
| Device dislodged or dislocated | 112 | 21% | 7% |
| Device expiration issue | 36 | 6.8% | 0.5% |
| Detachment of device or device componentpart of the device came off | 22 | 4.1% | 0.2% |
| Leak/splashthe device leaked | 22 | 4.1% | 2.7% |
| Device slipped | 12 | 2.3% | 0.4% |
| Burst container or vessel | 6 | 1.1% | 0.1% |
| Activation, positioning or separation problem | 5 | 0.9% | 0.3% |
| Deflation problem | 5 | 0.9% | 2.2% |
| Inflation problem | 5 | 0.9% | 2.5% |
| Failure to advance | 4 | 0.8% | 20.9% |
| Fracturea broken bone | 4 | 0.8% | 1% |
| Improper or incorrect procedure or method | 4 | 0.8% | 5.4% |
| Insufficient device problem information | 4 | 0.8% | 0.3% |
| Occlusion within devicethe device blocked | 4 | 0.8% | 4.7% |
| Breakthe device broke | 3 | 0.6% | 2.2% |
| Difficult or delayed positioning | 3 | 0.6% | 3% |
| Difficult to removethe device was hard to remove | 3 | 0.6% | 10.2% |
| Component missing | 2 | 0.4% | 0.5% |
| Component or accessory incompatibility | 2 | 0.4% | 0% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 44 | 8.3% |
| Myocardial infarctionheart attack | 30 | 5.6% |
| Reactiona reaction, type not specified | 24 | 4.5% |
| Thrombus | 20 | 3.8% |
| Occlusion | 17 | 3.2% |
| Injurya physical injury | 14 | 2.6% |
| Stenosis | 12 | 2.3% |
| Intimal dissection | 11 | 2.1% |
| Chest painchest pain | 9 | 1.7% |
| Device embedded in tissue or plaque | 9 | 1.7% |
| Aneurysm | 5 | 0.9% |
| Nauseafeeling sick | 4 | 0.8% |
| Skin irritationirritated skin | 4 | 0.8% |
| Urticariahives | 4 | 0.8% |
| Vascular dissection | 4 | 0.8% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Integrity Rx | Product code MAF | All MAUDE reports |
|---|---|---|---|
| Reports | 533 | 23,279 | 26,136,888 |
| Share of that pool | — | 2.3% | 0% |
| Classified as death, per 1,000 reports | 84 | 76 | 9 |
| Classified as injury | 37.3% | 51.3% | 36.2% |
| Classified as malfunction | 54.2% | 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% |
| Graftmaster | 568 | 131 | 9.9% |
| Libert | 415 | 0 | 0.7% |
| Omega | 353 | 0 | 1.4% |
| 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 Integrity Rx reports
How many FDA reports name Integrity Rx?
533 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 (54.2%), injury (37.3%) and death (8.4%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
material deformation (27%), device dislodged or dislocated (21%), device expiration issue (6.8%), detachment of device or device component (4.1%) and leak/splash (4.1%). 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 Integrity Rx 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.