Device brand name · Coronary stent delivery system
Graftmaster: medical device reports filed with FDA
568 reports name it, 2019–2026. Manufacturer given most often on reports: Abbott Vascular. Product code MAF.
- 568
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 131
- reports, 12 months to August 2026
- 129 in the 12 months before
- 6.7%
- classified as malfunction
- 40.4% across the product code
- 9.9%
- classified as death, as reported
- 56 reports · not verified by FDA
FDA's MAUDE database holds 568 reports that name the brand "Graftmaster" (coronary stent delivery system), received between July 2019 and August 2026; the manufacturer given most often on reports is Abbott Vascular. Spellings of one product vary from report to report.
131 reports arrived in the 12 months to August 2026, close to the 129 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 (83.5%), death (9.9%) and malfunction (6.7%); 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 failure to advance (64.4%), patient-device incompatibility (20.4%) and improper or incorrect procedure or method (10.4%). The patient problems coded most often are cardiac arrest, death and cardiac tamponade. 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 |
|---|---|---|---|
| Failure to advance | 366 | 64.4% | 20.9% |
| Patient-device incompatibilitythe device did not suit the patient | 116 | 20.4% | 1.3% |
| Improper or incorrect procedure or method | 59 | 10.4% | 5.4% |
| Off-label use | 35 | 6.2% | 0.5% |
| Device dislodged or dislocated | 25 | 4.4% | 7% |
| Material separation | 24 | 4.2% | 3.5% |
| Difficult to advance | 21 | 3.7% | 0.7% |
| Deformation due to compressive stress | 12 | 2.1% | 0.3% |
| Difficult to removethe device was hard to remove | 11 | 1.9% | 10.2% |
| Material deformation | 9 | 1.6% | 3% |
| Activation failure | 8 | 1.4% | 0.2% |
| Material split, cut or torn | 5 | 0.9% | 0.1% |
| Difficult or delayed activation | 4 | 0.7% | 0.1% |
| Material rupture | 4 | 0.7% | 0.8% |
| Breakthe device broke | 3 | 0.5% | 2.2% |
| Difficult or delayed positioning | 3 | 0.5% | 3% |
| Insufficient device problem information | 3 | 0.5% | 0.3% |
| Device damaged by another device | 2 | 0.4% | 0.3% |
| Product quality problem | 2 | 0.4% | 0% |
| Contamination /decontamination problem | 1 | 0.2% | 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 |
|---|---|---|
| Cardiac arrestthe heart stopped | 27 | 4.8% |
| Deaththe patient died; cause not stated by this term | 21 | 3.7% |
| Cardiac tamponade | 19 | 3.3% |
| Low blood pressure/ hypotension | 14 | 2.5% |
| Pericardial effusionfluid around the heart | 13 | 2.3% |
| Foreign body in patientpart of a device left in the patient | 9 | 1.6% |
| Angina | 7 | 1.2% |
| Perforation | 7 | 1.2% |
| Respiratory failurethe lungs could not supply enough oxygen | 6 | 1.1% |
| Thrombosis/thrombus | 5 | 0.9% |
| Ventricular fibrillationa chaotic rhythm from the lower heart chambers | 5 | 0.9% |
| Cardiogenic shockshock from the heart failing to pump | 4 | 0.7% |
| Hemorrhage/blood loss/bleeding | 4 | 0.7% |
| Ischemia | 4 | 0.7% |
| No patient involvement | 3 | 0.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Graftmaster | Product code MAF | All MAUDE reports |
|---|---|---|---|
| Reports | 568 | 23,279 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 99 | 76 | 9 |
| Classified as injury | 83.5% | 51.3% | 36.2% |
| Classified as malfunction | 6.7% | 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% |
| 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 Graftmaster reports
How many FDA reports name Graftmaster?
568 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 131 in the latest 12 months.
What kinds of events are reported?
injury (83.5%), death (9.9%) and malfunction (6.7%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
failure to advance (64.4%), patient-device incompatibility (20.4%), improper or incorrect procedure or method (10.4%), off-label use (6.2%) and device dislodged or dislocated (4.4%). 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 Graftmaster 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.