Devices › System, endovascular graft, aortic aneurysm treatment
Device brand name · System endovascular graft aortic aneurysm treatment
GORE EXCLUDER AAA Endoprosthesis: medical device reports filed with FDA
9,590 reports name it, 2006–2026. Manufacturer given most often on reports: W L Gore & Associates. Product code MIH.
- 9,590
- device reports naming the brand
- 0% of all MAUDE reports · about 474 a year
- 633
- reports, 12 months to August 2026
- 671 in the 12 months before
- 7%
- classified as malfunction
- 14.8% across the product code
- 4.8%
- classified as death, as reported
- 459 reports · not verified by FDA
9,590 medical device reports received by FDA name the brand "GORE EXCLUDER AAA Endoprosthesis" (system endovascular graft aortic aneurysm treatment); the manufacturer given most often on reports is W L Gore & Associates; received from April 2006 to August 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
633 reports arrived in the 12 months to August 2026, close to the 671 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 (88.1%), malfunction (7%) and death (4.8%); 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 (22%), insufficient device problem information (11%) and patient-device incompatibility (10.8%). The patient problems coded most often are hemorrhage/blood loss/bleeding, aneurysm and clinical endoleak. 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 | 2,108 | 22% | 33.8% |
| Insufficient device problem information | 1,059 | 11% | 6.4% |
| Patient-device incompatibilitythe device did not suit the patient | 1,033 | 10.8% | 3.4% |
| Malposition of device | 692 | 7.2% | 3.9% |
| Device remains implanted | 495 | 5.2% | 3.6% |
| Migration or expulsion of device | 370 | 3.9% | 6.1% |
| Migrationthe device moved from where it was placed | 317 | 3.3% | 1.4% |
| Fluid/blood leak | 266 | 2.8% | 1.8% |
| Occlusion within devicethe device blocked | 194 | 2% | 5.4% |
| Explanted | 186 | 1.9% | 1.4% |
| Breakthe device broke | 182 | 1.9% | 1.3% |
| Device endoleak | 175 | 1.8% | 1.2% |
| Device operates differently than expectedthe device behaved unexpectedly | 154 | 1.6% | 0.7% |
| Activation, positioning or separation problem | 145 | 1.5% | 1.7% |
| Improper or incorrect procedure or method | 145 | 1.5% | 1.3% |
| Positioning problem | 143 | 1.5% | 0.8% |
| Patient device interaction problem | 139 | 1.4% | 0.7% |
| Material separation | 135 | 1.4% | 1% |
| Difficult to position | 110 | 1.1% | 1.5% |
| Detachment of device component | 109 | 1.1% | 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 |
|---|---|---|
| Hemorrhage/blood loss/bleeding | 2,035 | 21.2% |
| Aneurysm | 1,938 | 20.2% |
| Clinical endoleak | 1,020 | 10.6% |
| Aneurysm expansion | 611 | 6.4% |
| Obstruction/occlusion | 573 | 6% |
| Deaththe patient died; cause not stated by this term | 452 | 4.7% |
| Rupturethe device burst | 411 | 4.3% |
| Therapy/non-surgical treatment, additional | 396 | 4.1% |
| Bleeding | 358 | 3.7% |
| Occlusion | 330 | 3.4% |
| Surgical procedure | 248 | 2.6% |
| Surgical procedure, additional | 228 | 2.4% |
| Vascular dissection | 219 | 2.3% |
| Surgical procedure, repeated | 194 | 2% |
| Painpain, site not specified | 193 | 2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GORE EXCLUDER AAA Endoprosthesis | Product code MIH | All MAUDE reports |
|---|---|---|---|
| Reports | 9,590 | 72,039 | 26,136,888 |
| Share of that pool | — | 13.3% | 0% |
| Classified as death, per 1,000 reports | 48 | 98 | 9 |
| Classified as injury | 88.1% | 74.9% | 36.2% |
| Classified as malfunction | 7% | 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 |
|---|---|---|---|
| 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% |
| 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 GORE EXCLUDER AAA Endoprosthesis reports
How many FDA reports name GORE EXCLUDER AAA Endoprosthesis?
9,590 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 633 in the latest 12 months.
What kinds of events are reported?
injury (88.1%), malfunction (7%) and death (4.8%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
leak/splash (22%), insufficient device problem information (11%), patient-device incompatibility (10.8%), malposition of device (7.2%) and device remains implanted (5.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that GORE EXCLUDER AAA Endoprosthesis 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.