Devices › Prosthesis, vascular graft, of 6mm and greater diameter
Device brand name · Vascular graft
Hero Graft: medical device reports filed with FDA
441 reports name it, 2012–2016. Manufacturer given most often on reports: Cryolife. Product code DSY.
- 441
- device reports naming the brand
- 0% of all MAUDE reports · about 31 a year
- 0
- reports, 12 months to August 2026
- 0 in the 12 months before
- 2.9%
- classified as malfunction
- 20% across the product code
- 30.8%
- classified as death, as reported
- 136 reports · not verified by FDA
441 medical device reports received by FDA name the brand "Hero Graft" (vascular graft); the manufacturer given most often on reports is Cryolife; received from April 2012 to April 2016. 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 (64.6%), death (30.8%) and malfunction (2.9%); 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 (31.1%), device operates differently than expected (12.9%) and occlusion within device (10.2%). The patient problems coded most often are death, thrombosis and occlusion. 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 Hero Graft was received in the five years to August 2026; the latest was received in April 2016.
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 | 137 | 31.1% | 11.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 57 | 12.9% | 3.4% |
| Occlusion within devicethe device blocked | 45 | 10.2% | 8.3% |
| Complete blockage | 33 | 7.5% | 1.7% |
| Kinkedthe tube or line kinked | 14 | 3.2% | 0.5% |
| Migration or expulsion of device | 13 | 2.9% | 0.5% |
| Breakthe device broke | 4 | 0.9% | 0.9% |
| Device dislodged or dislocated | 4 | 0.9% | 0.1% |
| Leak/splashthe device leaked | 4 | 0.9% | 8% |
| Patient-device incompatibilitythe device did not suit the patient | 4 | 0.9% | 1.4% |
| Contamination | 3 | 0.7% | 1% |
| Material integrity problema problem with the device material | 3 | 0.7% | 1.5% |
| Detachment of device component | 2 | 0.5% | 0.6% |
| Difficult to position | 2 | 0.5% | 0.2% |
| Disconnection | 2 | 0.5% | 0.1% |
| Human-device interface problem | 2 | 0.5% | 0.1% |
| Improper flow or infusion | 2 | 0.5% | 0% |
| Infusion or flow problema problem with flow or infusion | 2 | 0.5% | 0.3% |
| Physical resistance | 2 | 0.5% | 0% |
| Positioning problem | 2 | 0.5% | 0.1% |
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 | 129 | 29.3% |
| Thrombosis | 92 | 20.9% |
| Occlusion | 33 | 7.5% |
| Pseudoaneurysm | 32 | 7.3% |
| Bacterial infectiona bacterial infection | 27 | 6.1% |
| Hematomaa collection of blood under the skin or in tissue | 27 | 6.1% |
| Seromaa collection of fluid under the skin | 25 | 5.7% |
| Abscessa collection of pus | 16 | 3.6% |
| Failure of implant | 16 | 3.6% |
| Thrombus | 16 | 3.6% |
| Hemorrhage/blood loss/bleeding | 12 | 2.7% |
| Impaired healingslow healing | 12 | 2.7% |
| Vascular system (circulation), impaired | 11 | 2.5% |
| Complaint, ill-defined | 10 | 2.3% |
| Pulmonary embolisma blood clot in the lung | 9 | 2% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Hero Graft | Product code DSY | All MAUDE reports |
|---|---|---|---|
| Reports | 441 | 5,193 | 26,136,888 |
| Share of that pool | — | 8.5% | 0% |
| Classified as death, per 1,000 reports | 308 | 72 | 9 |
| Classified as injury | 64.6% | 63.8% | 36.2% |
| Classified as malfunction | 2.9% | 20% | 62.3% |
| Filed by the manufacturer | 99.1% | 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% |
| GORE ACUSEAL Vascular Graft | 338 | 35 | 0.3% |
| Gore Hybrid Vascular Graft | 155 | 0 | 11.6% |
| 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 Hero Graft reports
How many FDA reports name Hero Graft?
441 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 (64.6%), death (30.8%) and malfunction (2.9%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
insufficient device problem information (31.1%), device operates differently than expected (12.9%), occlusion within device (10.2%), complete blockage (7.5%) and kinked (3.2%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.1%) and voluntary reports (0.9%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Hero 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.