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FDA product code MAF · class 3 · Unknown
Stent, coronary: medical device reports filed with FDA
23,279 reports carry this product code, 1993–2026; 30 brands with a page.
- 23,279
- reports with this product code
- 0.1% of all MAUDE reports
- 47
- reports, 12 months to August 2026
- 149 in the 12 months before
- 40.4%
- classified as malfunction
- 62.3% across all reports
- 7.6%
- classified as death, as reported
- 0.9% across all reports
Product code MAF is FDA's classification for "Stent, coronary" (unknown panel), a class 3 device. 23,279 medical device reports carry this product code, 0.1% of the MAUDE database, from October 1993 to July 2026.
47 reports arrived in the 12 months to August 2026, down 68% from 149 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 (51.3%), malfunction (40.4%) and death (7.6%). 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
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 |
|---|---|---|
| Av-Temecula-Ct | 4,050 | 17.4% |
| Boston Scientific | 2,831 | 12.2% |
| Guidant Vascular Intervention | 2,161 | 9.3% |
| Abbott Vascular-Cardiac Therapies | 2,028 | 8.7% |
| Boston Scientific - Maple Grove | 1,450 | 6.2% |
| Abbott Vascular | 1,293 | 5.6% |
| Medtronic Ireland | 928 | 4% |
| Boston Scientific Ireland | 807 | 3.5% |
| Boston Scientific - Galway | 707 | 3% |
| Cordis Miami | 629 | 2.7% |
| Cordis | 512 | 2.2% |
| Cordis De Mexico | 437 | 1.9% |
| Medtronic Cardiovascular Galway | 287 | 1.2% |
| Cordis Europa | 201 | 0.9% |
| Cook | 137 | 0.6% |
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
Who filed
Grey bar: all 26,136,888 MAUDE reports.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Failure to advance | 4,856 | 20.9% |
| Dislodged | 3,700 | 15.9% |
| Difficult to removethe device was hard to remove | 2,373 | 10.2% |
| Replace | 1,754 | 7.5% |
| Device dislodged or dislocated | 1,625 | 7% |
| Difficult to insertthe device was hard to insert | 1,569 | 6.7% |
| Device remains implanted | 1,474 | 6.3% |
| Improper or incorrect procedure or method | 1,254 | 5.4% |
| Occlusion within devicethe device blocked | 1,096 | 4.7% |
| Balloon rupture | 1,012 | 4.3% |
| Device damaged prior to usethe device was damaged before use | 892 | 3.8% |
| Other (for use when an appropriate device code cannot be identified) | 870 | 3.7% |
| Bent | 838 | 3.6% |
| Material separation | 811 | 3.5% |
| Device, or device fragments remain in patient | 782 | 3.4% |
| Detachment of device component | 769 | 3.3% |
| Difficult or delayed positioning | 705 | 3% |
| Material deformation | 695 | 3% |
| Positioning failure | 649 | 2.8% |
| Leak/splashthe device leaked | 638 | 2.7% |
Questions about stent, coronary reports
What is product code MAF?
FDA's classification code for "Stent, coronary", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.
How many reports carry this code?
23,279 reports through August 2026, 47 of them in the latest 12 months.
Which brands appear most often?
Graftmaster Rx Coronary Stent Graft System (2,163), Multi-Link Rx Vision Coronary Stent System (1,873), Jostent Graftmaster (1,368), Express2 Monorail Coronary Stent Delivery System (877) and Multi-Link Mini Vision Rx Coronary Stent System (867). 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.