Devices › Iliac covered stent, arterial
Device brand name · Iliac covered stent arterial
GORE VIABAHN VBX Balloon Expandable Endoprosthesis: medical device reports filed with FDA
1,485 reports name it, 2017–2026. Manufacturer given most often on reports: W L Gore & Associates. Product code PRL.
- 1,485
- device reports naming the brand
- 0% of all MAUDE reports · about 161 a year
- 295
- reports, 12 months to August 2026
- 280 in the 12 months before
- 29%
- classified as malfunction
- 57.9% across the product code
- 4.9%
- classified as death, as reported
- 73 reports · not verified by FDA
FDA's MAUDE database holds 1,485 reports that name the brand "GORE VIABAHN VBX Balloon Expandable Endoprosthesis" (iliac covered stent arterial), received between April 2017 and August 2026; the manufacturer given most often on reports is W L Gore & Associates. Spellings of one product vary from report to report.
295 reports arrived in the 12 months to August 2026, close to the 280 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 (66.1%), malfunction (29%) and death (4.9%); across all iliac covered stent, arterial reports (product code PRL) death is recorded in 2.8% and malfunction in 57.9%. Event type is the reporter's classification of the report, not a verified outcome.
The device problems coded most often are device dislodged or dislocated (12.2%), complete blockage (10.6%) and detachment of device or device component (8.1%). The patient problems coded most often are obstruction/occlusion, clinical endoleak and thrombosis/thrombus. 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 2,647 reports carrying product code PRL. 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 |
|---|---|---|---|
| Device dislodged or dislocated | 181 | 12.2% | 42.7% |
| Complete blockage | 157 | 10.6% | 5.8% |
| Detachment of device or device componentpart of the device came off | 121 | 8.1% | 4.3% |
| Obstruction of flow | 104 | 7% | 3.9% |
| Patient-device incompatibilitythe device did not suit the patient | 103 | 6.9% | 3.2% |
| Device endoleak | 77 | 5.2% | 3% |
| Collapse | 76 | 5.1% | 2.1% |
| Device stenosis | 74 | 5% | 2.9% |
| Premature separation | 71 | 4.8% | 2.8% |
| Insufficient device problem information | 66 | 4.4% | 1.9% |
| Partial blockage | 55 | 3.7% | 1.7% |
| Material deformation | 54 | 3.6% | 6.2% |
| Migrationthe device moved from where it was placed | 53 | 3.6% | 2.2% |
| Deformation due to compressive stress | 47 | 3.2% | 1.4% |
| Breakthe device broke | 26 | 1.8% | 1.5% |
| Difficult to removethe device was hard to remove | 22 | 1.5% | 1% |
| Activation failure | 21 | 1.4% | 0.8% |
| Difficult to advance | 20 | 1.3% | 1.7% |
| Patient device interaction problem | 20 | 1.3% | 0.5% |
| Malposition of device | 19 | 1.3% | 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 |
|---|---|---|
| Obstruction/occlusion | 217 | 14.6% |
| Clinical endoleak | 166 | 11.2% |
| Thrombosis/thrombus | 145 | 9.8% |
| Stenosis | 109 | 7.3% |
| Aneurysm | 84 | 5.7% |
| Occlusion | 74 | 5% |
| Foreign body in patientpart of a device left in the patient | 36 | 2.4% |
| Renal impairmentreduced kidney function | 33 | 2.2% |
| Vascular dissection | 32 | 2.2% |
| Renal failurekidney failure | 31 | 2.1% |
| Perforation of vessels | 30 | 2% |
| Reduced blood flow | 23 | 1.5% |
| Deaththe patient died; cause not stated by this term | 22 | 1.5% |
| Painpain, site not specified | 19 | 1.3% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 17 | 1.1% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GORE VIABAHN VBX Balloon Expandable Endoprosthesis | Product code PRL | All MAUDE reports |
|---|---|---|---|
| Reports | 1,485 | 2,647 | 26,136,888 |
| Share of that pool | — | 56.1% | 0% |
| Classified as death, per 1,000 reports | 49 | 28 | 9 |
| Classified as injury | 66.1% | 39.3% | 36.2% |
| Classified as malfunction | 29% | 57.9% | 62.3% |
| Filed by the manufacturer | 99.9% | 98.7% | 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 PRL
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Lifestream | 1,012 | 227 | 0.5% |
| Lifestream Balloon Expandable Vascular Covered Stent | 181 | 0 | 4.4% |
| GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface | 906 | 174 | 2.1% |
| GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface | 341 | 91 | 0.6% |
| Bard | 1,124 | 2 | 1.8% |
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 VIABAHN VBX Balloon Expandable Endoprosthesis reports
How many FDA reports name GORE VIABAHN VBX Balloon Expandable Endoprosthesis?
1,485 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 295 in the latest 12 months.
What kinds of events are reported?
injury (66.1%), malfunction (29%) and death (4.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
device dislodged or dislocated (12.2%), complete blockage (10.6%), detachment of device or device component (8.1%), obstruction of flow (7%) and patient-device incompatibility (6.9%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.9%) and voluntary reports (0.1%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that GORE VIABAHN VBX Balloon Expandable 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.