Devices › System, endovascular graft, aortic aneurysm treatment
Device brand name · Stent endovascular graft aortic
TREO Abdominal Stent-Graft System: medical device reports filed with FDA
779 reports name it, 2020–2026. Manufacturer given most often on reports: Bolton Medical. Product code MIH.
- 779
- device reports naming the brand
- 0% of all MAUDE reports · about 128 a year
- 130
- reports, 12 months to August 2026
- 154 in the 12 months before
- 28.2%
- classified as malfunction
- 14.8% across the product code
- 3.2%
- classified as death, as reported
- 25 reports · not verified by FDA
FDA's MAUDE database holds 779 reports that name the brand "TREO Abdominal Stent-Graft System" (stent endovascular graft aortic), received between June 2020 and August 2026; the manufacturer given most often on reports is Bolton Medical. Spellings of one product vary from report to report.
130 reports arrived in the 12 months to August 2026, down 16% from 154 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 (68.5%), malfunction (28.2%) and death (3.2%); across all system, endovascular graft, aortic aneurysm treatment reports (product code MIH) death is recorded in 9.8% and malfunction in 14.8%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device endoleak (22.3%), failure to seal (19.6%) and fluid/blood leak (10.4%). The patient problems coded most often are clinical endoleak, thrombosis/thrombus and aneurysm expansion. 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 72,039 reports carrying product code MIH. 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 |
|---|---|---|---|
| Device endoleak | 174 | 22.3% | 1.2% |
| Failure to seal | 153 | 19.6% | 0.4% |
| Fluid/blood leak | 81 | 10.4% | 1.8% |
| Obstruction of flow | 80 | 10.3% | 1% |
| Insufficient device problem information | 60 | 7.7% | 6.4% |
| Patient device interaction problem | 45 | 5.8% | 0.7% |
| Device stenosis | 44 | 5.6% | 0.2% |
| Leak/splashthe device leaked | 36 | 4.6% | 33.8% |
| Detachment of device or device componentpart of the device came off | 34 | 4.4% | 1% |
| Difficult or delayed separation | 31 | 4% | 0.2% |
| Retraction problem | 27 | 3.5% | 0.4% |
| Malposition of device | 22 | 2.8% | 3.9% |
| Improper or incorrect procedure or method | 16 | 2.1% | 1.3% |
| Failure to advance | 15 | 1.9% | 1.1% |
| Difficult to advance | 14 | 1.8% | 0.6% |
| Physical resistance/sticking | 14 | 1.8% | 0.2% |
| Positioning problem | 13 | 1.7% | 0.8% |
| Mechanical problema mechanical problem | 12 | 1.5% | 0.1% |
| Fracturea broken bone | 11 | 1.4% | 0.7% |
| Material separation | 11 | 1.4% | 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 |
|---|---|---|
| Clinical endoleak | 263 | 33.8% |
| Thrombosis/thrombus | 151 | 19.4% |
| Aneurysm expansion | 97 | 12.5% |
| Hemorrhage/blood loss/bleeding | 48 | 6.2% |
| Obstruction/occlusion | 48 | 6.2% |
| Reduced blood flow | 33 | 4.2% |
| Limb pain | 24 | 3.1% |
| Foreign body in patientpart of a device left in the patient | 22 | 2.8% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 21 | 2.7% |
| Thromboembolism | 20 | 2.6% |
| Stenosis | 18 | 2.3% |
| Ischemia | 12 | 1.5% |
| Aneurysm | 11 | 1.4% |
| Restenosis | 10 | 1.3% |
| Vascular dissection | 9 | 1.2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | TREO Abdominal Stent-Graft System | Product code MIH | All MAUDE reports |
|---|---|---|---|
| Reports | 779 | 72,039 | 26,136,888 |
| Share of that pool | — | 1.1% | 0% |
| Classified as death, per 1,000 reports | 32 | 98 | 9 |
| Classified as injury | 68.5% | 74.9% | 36.2% |
| Classified as malfunction | 28.2% | 14.8% | 62.3% |
| Filed by the manufacturer | 99.6% | 99% | 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 MIH
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| GORE EXCLUDER AAA Endoprosthesis | 9,590 | 633 | 4.8% |
| Afx | 3,584 | 30 | 5% |
| Gore Tag Thoracic Endoprosthesis | 2,829 | 4 | 14.7% |
| Endurant | 1,861 | 0 | 14.7% |
| Endurant Iis Bifurcated Stent Graft | 1,706 | 121 | 11.6% |
| Valiant Captivia - FF | 1,532 | 95 | 15.1% |
| GORE TAG Conformable Thoracic Stent Graft with ACTIVE CONTROL System | 1,474 | 311 | 7.7% |
| Endurant Stent Graft | 1,471 | 56 | 10% |
| Afx2 | 1,263 | 123 | 6.4% |
| Medtronic Aneurx Bifurcated Stent Graft Flexible | 1,263 | 0 | 9.7% |
| Zenith Flex AAA Endovascular Graft Bifurcated Main Body | 1,172 | 15 | 6.1% |
| Valiant Navion | 1,149 | 40 | 17.4% |
| Ancure Endograft System | 1,126 | 0 | 5.1% |
| Endurant Abdominal Stent Graft System | 997 | 0 | 12.9% |
| Afx System | 882 | 0 | 8.4% |
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 TREO Abdominal Stent-Graft System reports
How many FDA reports name TREO Abdominal Stent-Graft System?
779 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 130 in the latest 12 months.
What kinds of events are reported?
injury (68.5%), malfunction (28.2%) and death (3.2%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device endoleak (22.3%), failure to seal (19.6%), fluid/blood leak (10.4%), obstruction of flow (10.3%) and insufficient device problem information (7.7%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that TREO Abdominal Stent-Graft System 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.