Devices › System, endovascular graft, aortic aneurysm treatment
Device brand name · System endovascular graft aortic aneurysm treatment
Endurant Iis Bifurcated Stent Graft: medical device reports filed with FDA
1,706 reports name it, 2015–2026. Manufacturer given most often on reports: Medtronic Ireland. Product code MIH.
- 1,706
- device reports naming the brand
- 0% of all MAUDE reports · about 153 a year
- 121
- reports, 12 months to August 2026
- 134 in the 12 months before
- 22.3%
- classified as malfunction
- 14.8% across the product code
- 11.6%
- classified as death, as reported
- 198 reports · not verified by FDA
1,706 medical device reports received by FDA name the brand "Endurant Iis Bifurcated Stent Graft" (system endovascular graft aortic aneurysm treatment); the manufacturer given most often on reports is Medtronic Ireland; received from May 2015 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
121 reports arrived in the 12 months to August 2026, down 10% from 134 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 (66.1%), malfunction (22.3%) and death (11.6%); 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 leak/splash (51.7%), malposition of device (10.3%) and material deformation (9.8%). The patient problems coded most often are injury, occlusion and obstruction/occlusion. 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 |
|---|---|---|---|
| Leak/splashthe device leaked | 882 | 51.7% | 33.8% |
| Malposition of device | 175 | 10.3% | 3.9% |
| Material deformation | 168 | 9.8% | 1.4% |
| Activation, positioning or separation problem | 81 | 4.7% | 1.7% |
| Difficult to removethe device was hard to remove | 74 | 4.3% | 2.6% |
| Occlusion within devicethe device blocked | 51 | 3% | 5.4% |
| Detachment of device or device componentpart of the device came off | 46 | 2.7% | 1% |
| Device damaged by another device | 32 | 1.9% | 0.4% |
| Migration or expulsion of device | 30 | 1.8% | 6.1% |
| Difficult to insertthe device was hard to insert | 24 | 1.4% | 1% |
| Obstruction of flow | 19 | 1.1% | 1% |
| Fracturea broken bone | 17 | 1% | 0.7% |
| Difficult to position | 13 | 0.8% | 1.5% |
| Positioning problem | 13 | 0.8% | 0.8% |
| Breakthe device broke | 9 | 0.5% | 1.3% |
| Defective devicethe device was defective | 9 | 0.5% | 0.1% |
| Folded | 9 | 0.5% | 0.3% |
| Material twisted/bent | 8 | 0.5% | 0.2% |
| Device dislodged or dislocated | 7 | 0.4% | 0.6% |
| Insufficient device problem information | 7 | 0.4% | 6.4% |
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 |
|---|---|---|
| Injurya physical injury | 373 | 21.9% |
| Occlusion | 144 | 8.4% |
| Obstruction/occlusion | 103 | 6% |
| Painpain, site not specified | 98 | 5.7% |
| Deaththe patient died; cause not stated by this term | 85 | 5% |
| Rupturethe device burst | 74 | 4.3% |
| Hemorrhage/blood loss/bleeding | 51 | 3% |
| Renal failurekidney failure | 43 | 2.5% |
| Ischemia | 39 | 2.3% |
| Perforation of vessels | 37 | 2.2% |
| Vascular dissection | 29 | 1.7% |
| Fever | 24 | 1.4% |
| Low blood pressure/ hypotension | 24 | 1.4% |
| Blood loss | 23 | 1.3% |
| Cardiac arrestthe heart stopped | 23 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Endurant Iis Bifurcated Stent Graft | Product code MIH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,706 | 72,039 | 26,136,888 |
| Share of that pool | — | 2.4% | 0% |
| Classified as death, per 1,000 reports | 116 | 98 | 9 |
| Classified as injury | 66.1% | 74.9% | 36.2% |
| Classified as malfunction | 22.3% | 14.8% | 62.3% |
| Filed by the manufacturer | 99.9% | 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% |
| 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% |
| Ovation IX | 870 | 45 | 3.1% |
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 Endurant Iis Bifurcated Stent Graft reports
How many FDA reports name Endurant Iis Bifurcated Stent Graft?
1,706 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 121 in the latest 12 months.
What kinds of events are reported?
injury (66.1%), malfunction (22.3%) and death (11.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (51.7%), malposition of device (10.3%), material deformation (9.8%), activation, positioning or separation problem (4.7%) and difficult to remove (4.3%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Endurant Iis Bifurcated Stent Graft 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.