Devices › Prosthesis, vascular graft, of 6mm and greater diameter
Device brand name · Prosthesis vascular graft
Gore Hybrid Vascular Graft: medical device reports filed with FDA
155 reports name it, 2010–2017. Manufacturer given most often on reports: W L Gore & Associates. Product code DSY.
- 155
- device reports naming the brand
- 0% of all MAUDE reports · about 10 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 14.8%
- classified as malfunction
- 20% across the product code
- 11.6%
- classified as death, as reported
- 18 reports · not verified by FDA
155 medical device reports received by FDA name the brand "Gore Hybrid Vascular Graft" (prosthesis vascular graft); the manufacturer given most often on reports is W L Gore & Associates; received from October 2010 to November 2017. 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 (72.9%), malfunction (14.8%) and death (11.6%); across all prosthesis, vascular graft, of 6mm and greater diameter reports (product code DSY) death is recorded in 7.2% and malfunction in 20%. 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 (22.6%), occlusion within device (20%) and device operates differently than expected (9%). The patient problems coded most often are death, vascular system (circulation), impaired and 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
No report naming Gore Hybrid Vascular Graft was received in the five years to August 2026; the latest was received in November 2017.
By year received
Event type and report source
Event type, as classified on the report
Who filed the report
Grey bar: all 5,193 reports carrying product code DSY. 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 |
|---|---|---|---|
| Insufficient device problem information | 35 | 22.6% | 11.7% |
| Occlusion within devicethe device blocked | 31 | 20% | 8.3% |
| Device operates differently than expectedthe device behaved unexpectedly | 14 | 9% | 3.4% |
| Sticking | 6 | 3.9% | 0.1% |
| Activation, positioning or separation problem | 5 | 3.2% | 0% |
| Breakthe device broke | 4 | 2.6% | 0.9% |
| Collapse | 4 | 2.6% | 0.1% |
| Kinkedthe tube or line kinked | 4 | 2.6% | 0.5% |
| Positioning failure | 4 | 2.6% | 0.2% |
| Infusion or flow problema problem with flow or infusion | 3 | 1.9% | 0.3% |
| Material deformation | 3 | 1.9% | 0.4% |
| Obstruction of flow | 3 | 1.9% | 2.7% |
| Contamination of device ingredient or reagent | 2 | 1.3% | 0.1% |
| Difficult or delayed positioning | 2 | 1.3% | 0% |
| Difficult to removethe device was hard to remove | 2 | 1.3% | 0.3% |
| Extrusion | 2 | 1.3% | 0.1% |
| Migration or expulsion of device | 2 | 1.3% | 0.5% |
| Premature activation | 2 | 1.3% | 0.1% |
| Activation failure | 1 | 0.6% | 0% |
| Complete blockage | 1 | 0.6% | 1.7% |
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 |
|---|---|---|
| Deaththe patient died; cause not stated by this term | 20 | 12.9% |
| Vascular system (circulation), impaired | 20 | 12.9% |
| Thrombus | 18 | 11.6% |
| Thrombosis | 13 | 8.4% |
| Hemorrhage/blood loss/bleeding | 11 | 7.1% |
| Ischemia | 11 | 7.1% |
| Occlusion | 5 | 3.2% |
| Renal failurekidney failure | 5 | 3.2% |
| Sepsisa severe body-wide response to infection | 5 | 3.2% |
| Hematomaa collection of blood under the skin or in tissue | 4 | 2.6% |
| Necrosisdeath of tissue | 4 | 2.6% |
| Painpain, site not specified | 4 | 2.6% |
| Seromaa collection of fluid under the skin | 4 | 2.6% |
| Tissue damage | 4 | 2.6% |
| Collapse | 3 | 1.9% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gore Hybrid Vascular Graft | Product code DSY | All MAUDE reports |
|---|---|---|---|
| Reports | 155 | 5,193 | 26,136,888 |
| Share of that pool | — | 3% | 0% |
| Classified as death, per 1,000 reports | 116 | 72 | 9 |
| Classified as injury | 72.9% | 63.8% | 36.2% |
| Classified as malfunction | 14.8% | 20% | 62.3% |
| Filed by the manufacturer | 100% | 93.1% | 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 DSY
| Brand | Reports | Latest 12 months | Classified as death |
|---|---|---|---|
| Gore Propaten Vascular Graft | 508 | 13 | 2.6% |
| Hero Graft | 441 | 0 | 30.8% |
| GORE ACUSEAL Vascular Graft | 338 | 35 | 0.3% |
| Gore-Tex Stretch Vascular Graft | 159 | 0 | 3.8% |
| Hemashield Microvel Double Velour Graft | 407 | 0 | 6.4% |
| Gore Tag Thoracic Endoprosthesis | 2,829 | 4 | 14.7% |
| Jostent Graftmaster | 1,373 | 0 | 23.5% |
| Advanta V12 Covered Stent | 340 | 0 | 12.6% |
| Asku | 4,752 | 210 | 1.1% |
| GORE EXCLUDER AAA Endoprosthesis | 9,590 | 633 | 4.8% |
| Zenith Aaa Main Body Graft | 472 | 0 | 3.2% |
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 Hybrid Vascular Graft reports
How many FDA reports name Gore Hybrid Vascular Graft?
155 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 (72.9%), malfunction (14.8%) and death (11.6%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (22.6%), occlusion within device (20%), device operates differently than expected (9%), sticking (3.9%) and activation, positioning or separation problem (3.2%). 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 Hybrid Vascular Graft 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.