Devices › System, endovascular graft, aortic aneurysm treatment
Device brand name · Infrarenal bifurcated stent graft
Afx System: medical device reports filed with FDA
882 reports name it, 2011–2015. Manufacturer given most often on reports: Endologix. Product code MIH.
- 882
- device reports naming the brand
- 0% of all MAUDE reports · about 59 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 8.3%
- classified as malfunction
- 14.8% across the product code
- 8.4%
- classified as death, as reported
- 74 reports · not verified by FDA
882 medical device reports received by FDA name the brand "Afx System" (infrarenal bifurcated stent graft); the manufacturer given most often on reports is Endologix; received from September 2011 to October 2015. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
0 reports arrived in the 12 months to August 2026, and none 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 (82.3%), death (8.4%) and malfunction (8.3%); 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 (59.4%), insufficient device problem information (10.3%) and occlusion within device (6.8%). The patient problems coded most often are hemorrhage/blood loss/bleeding, death and rupture. 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
No report naming Afx System was received in the five years to August 2026; the latest was received in October 2015.
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 | 524 | 59.4% | 33.8% |
| Insufficient device problem information | 91 | 10.3% | 6.4% |
| Occlusion within devicethe device blocked | 60 | 6.8% | 5.4% |
| Material separation | 39 | 4.4% | 1% |
| Failure to adhere or bond | 33 | 3.7% | 1.8% |
| Device operates differently than expectedthe device behaved unexpectedly | 29 | 3.3% | 0.7% |
| Detachment of device component | 24 | 2.7% | 0.7% |
| Migration or expulsion of device | 23 | 2.6% | 6.1% |
| Kinkedthe tube or line kinked | 17 | 1.9% | 1.7% |
| Breakthe device broke | 15 | 1.7% | 1.3% |
| Hole in material | 15 | 1.7% | 1% |
| Malposition of device | 15 | 1.7% | 3.9% |
| Retraction problem | 14 | 1.6% | 0.4% |
| Difficult or delayed positioning | 13 | 1.5% | 1.4% |
| Difficult to advance | 12 | 1.4% | 0.6% |
| Positioning problem | 11 | 1.2% | 0.8% |
| Disconnection | 9 | 1% | 0.2% |
| Device dislodged or dislocated | 8 | 0.9% | 0.6% |
| Material rupture | 8 | 0.9% | 0.2% |
| Collapse | 7 | 0.8% | 0.4% |
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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 562 | 63.7% |
| Deaththe patient died; cause not stated by this term | 96 | 10.9% |
| Rupturethe device burst | 72 | 8.2% |
| Abdominal painstomach or belly pain | 60 | 6.8% |
| Painpain, site not specified | 57 | 6.5% |
| Aneurysm | 47 | 5.3% |
| Failure of implant | 46 | 5.2% |
| Occlusion | 39 | 4.4% |
| Low blood pressure/ hypotension | 32 | 3.6% |
| Thrombus | 30 | 3.4% |
| Thrombosis | 26 | 2.9% |
| Ischemia | 16 | 1.8% |
| Therapeutic response, decreased | 16 | 1.8% |
| Blood loss | 10 | 1.1% |
| Calcium deposits/calcification | 10 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Afx System | Product code MIH | All MAUDE reports |
|---|---|---|---|
| Reports | 882 | 72,039 | 26,136,888 |
| Share of that pool | — | 1.2% | 0% |
| Classified as death, per 1,000 reports | 84 | 98 | 9 |
| Classified as injury | 82.3% | 74.9% | 36.2% |
| Classified as malfunction | 8.3% | 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% |
| 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% |
| 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 Afx System reports
How many FDA reports name Afx System?
882 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 0 in the latest 12 months.
What kinds of events are reported?
injury (82.3%), death (8.4%) and malfunction (8.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (59.4%), insufficient device problem information (10.3%), occlusion within device (6.8%), material separation (4.4%) and failure to adhere or bond (3.7%). 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 Afx 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.