Devices › Prosthesis, vascular graft, of 6mm and greater diameter
Device brand name · Prosthesis vascular graft
Gore-Tex Stretch Vascular Graft: medical device reports filed with FDA
159 reports name it, 2006–2025. Manufacturer given most often on reports: W L Gore & Associates. Product code DSY.
- 159
- device reports naming the brand
- 0% of all MAUDE reports · about 8 a year
- 0
- reports, 12 months to August 2026
- 7 in the 12 months before
- 1.3%
- classified as malfunction
- 20% across the product code
- 3.8%
- classified as death, as reported
- 6 reports · not verified by FDA
FDA's MAUDE database holds 159 reports that name the brand "Gore-Tex Stretch Vascular Graft" (prosthesis vascular graft), received between October 2006 and July 2025; the manufacturer given most often on reports is W L Gore & Associates. Spellings of one product vary from report to report.
0 reports arrived in the 12 months to August 2026, against 7 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 (95%), death (3.8%) and malfunction (1.3%); 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 microbial contamination of device (6.3%), insufficient device problem information (5%) and occlusion within device (3.8%). The patient problems coded most often are thrombosis, bacterial infection 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 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 |
|---|---|---|---|
| Microbial contamination of device | 10 | 6.3% | 0.9% |
| Insufficient device problem information | 8 | 5% | 11.7% |
| Occlusion within devicethe device blocked | 6 | 3.8% | 8.3% |
| Obstruction of flow | 5 | 3.1% | 2.7% |
| Partial blockage | 5 | 3.1% | 0.7% |
| Contamination | 4 | 2.5% | 1% |
| Complete blockage | 3 | 1.9% | 1.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 3 | 1.9% | 3.4% |
| Patient-device incompatibilitythe device did not suit the patient | 2 | 1.3% | 1.4% |
| Contamination /decontamination problem | 1 | 0.6% | 0.1% |
| Device stenosis | 1 | 0.6% | 1.1% |
| Fluid/blood leak | 1 | 0.6% | 2.8% |
| Leak/splashthe device leaked | 1 | 0.6% | 8% |
| Material split, cut or torn | 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 |
|---|---|---|
| Thrombosis | 13 | 8.2% |
| Bacterial infectiona bacterial infection | 8 | 5% |
| Thrombosis/thrombus | 8 | 5% |
| Hematomaa collection of blood under the skin or in tissue | 7 | 4.4% |
| Aneurysm | 4 | 2.5% |
| Ischemia | 4 | 2.5% |
| Obstruction/occlusion | 4 | 2.5% |
| Stenosis | 4 | 2.5% |
| Thrombus | 4 | 2.5% |
| Post operative wound infection | 3 | 1.9% |
| Seromaa collection of fluid under the skin | 3 | 1.9% |
| Appropriate clinical signs, symptoms and conditions term/code not available | 2 | 1.3% |
| Hemorrhage/blood loss/bleeding | 2 | 1.3% |
| Occlusion | 2 | 1.3% |
| Pseudoaneurysm | 2 | 1.3% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | Gore-Tex Stretch Vascular Graft | Product code DSY | All MAUDE reports |
|---|---|---|---|
| Reports | 159 | 5,193 | 26,136,888 |
| Share of that pool | — | 3.1% | 0% |
| Classified as death, per 1,000 reports | 38 | 72 | 9 |
| Classified as injury | 95% | 63.8% | 36.2% |
| Classified as malfunction | 1.3% | 20% | 62.3% |
| Filed by the manufacturer | 98.7% | 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 Hybrid Vascular Graft | 155 | 0 | 11.6% |
| 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-Tex Stretch Vascular Graft reports
How many FDA reports name Gore-Tex Stretch Vascular Graft?
159 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 (95%), death (3.8%) and malfunction (1.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
microbial contamination of device (6.3%), insufficient device problem information (5%), occlusion within device (3.8%), obstruction of flow (3.1%) and partial blockage (3.1%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (98.7%) and voluntary reports (0.6%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that Gore-Tex Stretch 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.