Devices › Prosthesis, vascular graft, of 6mm and greater diameter
Device brand name · Prosthesis vascular graft
GORE ACUSEAL Vascular Graft: medical device reports filed with FDA
338 reports name it, 2013–2026. Manufacturer given most often on reports: W L Gore & Associates. Product code DSY.
- 338
- device reports naming the brand
- 0% of all MAUDE reports · about 26 a year
- 35
- reports, 12 months to August 2026
- 45 in the 12 months before
- 8%
- classified as malfunction
- 20% across the product code
- 0.3%
- classified as death, as reported
- 1 reports · not verified by FDA
338 medical device reports received by FDA name the brand "GORE ACUSEAL Vascular Graft" (prosthesis vascular graft); the manufacturer given most often on reports is W L Gore & Associates; received from September 2013 to July 2026. Brand names are as the reporter or manufacturer wrote them, so one product can appear under several spellings.
35 reports arrived in the 12 months to August 2026, down 22% from 45 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 (91.7%), malfunction (8%) and death (0.3%); 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 peeled/delaminated (40.5%), device stenosis (10.9%) and insufficient device problem information (8.3%). The patient problems coded most often are obstruction/occlusion, stenosis 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 |
|---|---|---|---|
| Peeled/delaminated | 137 | 40.5% | 3.9% |
| Device stenosis | 37 | 10.9% | 1.1% |
| Insufficient device problem information | 28 | 8.3% | 11.7% |
| Material separation | 19 | 5.6% | 1.7% |
| Occlusion within devicethe device blocked | 19 | 5.6% | 8.3% |
| Complete blockage | 12 | 3.6% | 1.7% |
| Device operates differently than expectedthe device behaved unexpectedly | 12 | 3.6% | 3.4% |
| Material split, cut or torn | 11 | 3.3% | 1.7% |
| Patient-device incompatibilitythe device did not suit the patient | 11 | 3.3% | 1.4% |
| Mechanical problema mechanical problem | 10 | 3% | 0.3% |
| Partial blockage | 10 | 3% | 0.7% |
| Obstruction of flow | 9 | 2.7% | 2.7% |
| Material puncture/hole | 7 | 2.1% | 1% |
| Contamination | 6 | 1.8% | 1% |
| Microbial contamination of device | 5 | 1.5% | 0.9% |
| Material rupture | 3 | 0.9% | 1.3% |
| No flow | 3 | 0.9% | 0% |
| Activation failure | 2 | 0.6% | 0% |
| Breakthe device broke | 2 | 0.6% | 0.9% |
| Human-device interface problem | 2 | 0.6% | 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 |
|---|---|---|
| Obstruction/occlusion | 55 | 16.3% |
| Stenosis | 53 | 15.7% |
| Thrombosis/thrombus | 50 | 14.8% |
| Thrombosis | 27 | 8% |
| Occlusion | 21 | 6.2% |
| Thrombus | 20 | 5.9% |
| Hematomaa collection of blood under the skin or in tissue | 19 | 5.6% |
| Reduced blood flow | 17 | 5% |
| Vascular dissection | 11 | 3.3% |
| Bacterial infectiona bacterial infection | 7 | 2.1% |
| Ischemia | 6 | 1.8% |
| Pseudoaneurysm | 6 | 1.8% |
| Deaththe patient died; cause not stated by this term | 5 | 1.5% |
| Failure of implant | 5 | 1.5% |
| Sepsisa severe body-wide response to infection | 5 | 1.5% |
Patient problem codes are present mainly in reports filed since 2019 and are often blank.
In context
| Measure | GORE ACUSEAL Vascular Graft | Product code DSY | All MAUDE reports |
|---|---|---|---|
| Reports | 338 | 5,193 | 26,136,888 |
| Share of that pool | — | 6.5% | 0% |
| Classified as death, per 1,000 reports | 3 | 72 | 9 |
| Classified as injury | 91.7% | 63.8% | 36.2% |
| Classified as malfunction | 8% | 20% | 62.3% |
| Filed by the manufacturer | 99.7% | 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 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 GORE ACUSEAL Vascular Graft reports
How many FDA reports name GORE ACUSEAL Vascular Graft?
338 medical device reports in the openFDA MAUDE release of 28 Sep 2026, covering reports received through August 2026; 35 in the latest 12 months.
What kinds of events are reported?
injury (91.7%), malfunction (8%) and death (0.3%). "Event type" is how the report was classified when filed: death, injury, malfunction or other.
What device problems are coded?
peeled/delaminated (40.5%), device stenosis (10.9%), insufficient device problem information (8.3%), material separation (5.6%) and occlusion within device (5.6%). These are FDA's device problem codes as entered on the report.
Who files these reports?
manufacturer reports (99.7%). Manufacturers and user facilities are required to report; voluntary reports come from health professionals and the public.
Do these reports show that GORE ACUSEAL 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.