Devices › System, endovascular graft, aortic aneurysm treatment
Device brand name · Mih system endovascular graft aortic aneurysm treatment
Zenith Flex AAA Endovascular Graft Bifurcated Main Body: medical device reports filed with FDA
1,172 reports name it, 2008–2026. Manufacturer given most often on reports: Cook. Product code MIH.
- 1,172
- device reports naming the brand
- 0% of all MAUDE reports · about 65 a year
- 15
- reports, 12 months to August 2026
- 24 in the 12 months before
- 28.5%
- classified as malfunction
- 14.8% across the product code
- 6.1%
- classified as death, as reported
- 72 reports · not verified by FDA
FDA's MAUDE database holds 1,172 reports that name the brand "Zenith Flex AAA Endovascular Graft Bifurcated Main Body" (mih system endovascular graft aortic aneurysm treatment), received between July 2008 and July 2026; the manufacturer given most often on reports is Cook. Spellings of one product vary from report to report.
15 reports arrived in the 12 months to August 2026, down 37% from 24 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 (65%), malfunction (28.5%) and death (6.1%); 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 (46.6%), difficult or delayed positioning (9.9%) and fluid/blood leak (6.7%). The patient problems coded most often are surgical procedure, additional, blood loss and surgery, prolonged. 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 | 546 | 46.6% | 33.8% |
| Difficult or delayed positioning | 116 | 9.9% | 1.4% |
| Fluid/blood leak | 79 | 6.7% | 1.8% |
| Occlusion within devicethe device blocked | 71 | 6.1% | 5.4% |
| Difficult to removethe device was hard to remove | 53 | 4.5% | 2.6% |
| Other (for use when an appropriate device code cannot be identified) | 53 | 4.5% | 1.4% |
| Explanted | 34 | 2.9% | 1.4% |
| Migration or expulsion of device | 23 | 2% | 6.1% |
| Material separation | 17 | 1.5% | 1% |
| Device endoleak | 15 | 1.3% | 1.2% |
| Material rupture | 15 | 1.3% | 0.2% |
| Difficult to advance | 14 | 1.2% | 0.6% |
| Dissection | 14 | 1.2% | 0.1% |
| Obstruction of flow | 13 | 1.1% | 1% |
| Migrationthe device moved from where it was placed | 12 | 1% | 1.4% |
| Activation, positioning or separation problem | 11 | 0.9% | 1.7% |
| Detachment of device or device componentpart of the device came off | 11 | 0.9% | 1% |
| Difficult or delayed activation | 10 | 0.9% | 0.2% |
| Hole in material | 10 | 0.9% | 1% |
| Lack of effect | 9 | 0.8% | 0.7% |
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 |
|---|---|---|
| Surgical procedure, additional | 162 | 13.8% |
| Blood loss | 128 | 10.9% |
| Surgery, prolonged | 82 | 7% |
| Occlusion | 63 | 5.4% |
| Deaththe patient died; cause not stated by this term | 62 | 5.3% |
| Other (for use when an appropriate patient code cannot be identified) | 59 | 5% |
| Clinical endoleak | 40 | 3.4% |
| Rupturethe device burst | 35 | 3% |
| Aneurysm expansion | 19 | 1.6% |
| Aneurysm | 16 | 1.4% |
| Thrombus | 15 | 1.3% |
| Abdominal painstomach or belly pain | 13 | 1.1% |
| Hemorrhage/blood loss/bleeding | 12 | 1% |
| Ischemia | 11 | 0.9% |
| Painpain, site not specified | 10 | 0.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Zenith Flex AAA Endovascular Graft Bifurcated Main Body | Product code MIH | All MAUDE reports |
|---|---|---|---|
| Reports | 1,172 | 72,039 | 26,136,888 |
| Share of that pool | — | 1.6% | 0% |
| Classified as death, per 1,000 reports | 61 | 98 | 9 |
| Classified as injury | 65% | 74.9% | 36.2% |
| Classified as malfunction | 28.5% | 14.8% | 62.3% |
| Filed by the manufacturer | 100% | 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% |
| 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 Zenith Flex AAA Endovascular Graft Bifurcated Main Body reports
How many FDA reports name Zenith Flex AAA Endovascular Graft Bifurcated Main Body?
1,172 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 15 in the latest 12 months.
What kinds of events are reported?
injury (65%), malfunction (28.5%) and death (6.1%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (46.6%), difficult or delayed positioning (9.9%), fluid/blood leak (6.7%), occlusion within device (6.1%) and difficult to remove (4.5%). 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 Zenith Flex AAA Endovascular Graft Bifurcated Main Body 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.