Device brand name · Endovascular system for treatment of thoracoabdominal and pararenal aortic lesio
GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis: medical device reports filed with FDA
162 reports name it, 2024–2026. Manufacturer given most often on reports: W L Gore & Associates.
- 162
- device reports naming the brand
- 0% of all MAUDE reports · about 81 a year
- 102
- reports, 12 months to August 2026
- 51 in the 12 months before
- 13.6%
- classified as malfunction
- 62.3% across all reports
- 14.2%
- classified as death, as reported
- 23 reports · not verified by FDA
FDA's MAUDE database holds 162 reports that name the brand "GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis" (endovascular system for treatment of thoracoabdominal and pararenal aortic lesio), received between July 2024 and August 2026; the manufacturer given most often on reports is W L Gore & Associates. Spellings of one product vary from report to report.
102 reports arrived in the 12 months to August 2026, up 100% from 51 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 (72.2%), death (14.2%) and malfunction (13.6%). Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are insufficient device problem information (11.7%), device endoleak (10.5%) and obstruction of flow (6.2%). The patient problems coded most often are ischemia, clinical endoleak and vascular dissection. 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 26,136,888 MAUDE reports. Event type is the filer's classification and is not verified by FDA.
Device problems coded
| Device problem (FDA code) | Reports | Share |
|---|---|---|
| Insufficient device problem information | 19 | 11.7% |
| Device endoleak | 17 | 10.5% |
| Obstruction of flow | 10 | 6.2% |
| Patient-device incompatibilitythe device did not suit the patient | 10 | 6.2% |
| Patient device interaction problem | 9 | 5.6% |
| Fracturea broken bone | 8 | 4.9% |
| Fluid/blood leak | 5 | 3.1% |
| Malposition of device | 5 | 3.1% |
| Detachment of device or device componentpart of the device came off | 3 | 1.9% |
| Migrationthe device moved from where it was placed | 3 | 1.9% |
| Activation failure | 2 | 1.2% |
| Complete blockage | 2 | 1.2% |
| Device damaged by another device | 1 | 0.6% |
| Device handling problem | 1 | 0.6% |
| Difficult or delayed positioning | 1 | 0.6% |
| Failure to advance | 1 | 0.6% |
| Improper or incorrect procedure or method | 1 | 0.6% |
| Off-label use | 1 | 0.6% |
| Partial blockage | 1 | 0.6% |
| Positioning failure | 1 | 0.6% |
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 |
|---|---|---|
| Ischemia | 25 | 15.4% |
| Clinical endoleak | 24 | 14.8% |
| Vascular dissection | 16 | 9.9% |
| Paralysis | 14 | 8.6% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 12 | 7.4% |
| Obstruction/occlusion | 11 | 6.8% |
| Renal impairmentreduced kidney function | 9 | 5.6% |
| Reduced blood flow | 7 | 4.3% |
| Paraplegia | 6 | 3.7% |
| Stroke/cva | 6 | 3.7% |
| Aneurysm expansion | 5 | 3.1% |
| Embolism/embolus | 5 | 3.1% |
| Aneurysm | 4 | 2.5% |
| Paresis | 4 | 2.5% |
| Thrombosis/thrombus | 4 | 2.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis | All MAUDE reports |
|---|---|---|
| Reports | 162 | 26,136,888 |
| Share of that pool | — | 0% |
| Classified as death, per 1,000 reports | 142 | 9 |
| Classified as injury | 72.2% | 36.2% |
| Classified as malfunction | 13.6% | 62.3% |
| Filed by the manufacturer | 100% | 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."
Questions about GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis reports
How many FDA reports name GORE EXCLUDER Thoracoabdominal Branch Endoprosthesis?
162 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 102 in the latest 12 months.
What kinds of events are reported?
injury (72.2%), death (14.2%) and malfunction (13.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (11.7%), device endoleak (10.5%), obstruction of flow (6.2%), patient-device incompatibility (6.2%) and patient device interaction problem (5.6%). 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 GORE EXCLUDER Thoracoabdominal Branch 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.