Prosthesis, vascular graft, of 6mm and greater diameter: medical device reports filed with FDA

5,193 reports carry this product code, 1992–2026; 12 brands with a page.

Read first · FDA's statement on these data

Adverse event reports submitted to FDA do not undergo extensive validation or verification. Therefore, a causal relationship cannot be established between product and reactions listed in a report. While a suspected relationship may exist, it is not medically validated and should not be the sole source of information for clinical decision making or other assumptions about the safety or efficacy of a product. Additionally, it is important to remember that adverse event reports represent a small percentage of total usage numbers of a product. Common products may have a higher number of adverse events due to the higher total number of people using the product. openFDA, FDA

FDA adds: "Although MDRs are a valuable source of information, this passive surveillance system has limitations, including the potential submission of incomplete, inaccurate, untimely, unverified, or biased data. In addition, the incidence or prevalence of an event cannot be determined from this reporting system alone due to potential under-reporting of events and lack of information about frequency of device use." And: "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."

Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated.

Not medical advice. This site counts what was reported to FDA. Questions about a medicine or device belong with a pharmacist or clinician.

5,193
reports with this product code: 0% of all MAUDE reports; 209
reports, 12 months to August 2026: 145 in the 12 months before; 20%
classified as malfunction: 62.3% across all reports; 7.2%
classified as death, as reported: 0.9% across all reports

Product code DSY is FDA's classification for "Prosthesis, vascular graft, of 6mm and greater diameter" (cardiovascular panel), a class 2 device. 5,193 medical device reports carry this product code, 0% of the MAUDE database, from January 1992 to August 2026.

209 reports arrived in the 12 months to August 2026, up 44% from 145 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 (63.8%), malfunction (20%) and death (7.2%). 12 brand names with a page on this site carry this code; the brands table is 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."

Brands with this product code

Brand	Reports	Latest 12 months	Classified as death	Classified as malfunction
Gore Propaten Vascular Graft	505	13	2.6%	1.6%
Hero Graft	441	0	30.8%	2.9%
GORE ACUSEAL Vascular Graft	338	35	0.3%	8%
Gore Hybrid Vascular Graft	155	0	11.6%	14.8%
Gore-Tex Stretch Vascular Graft	155	0	3.8%	1.3%
Hemashield Microvel Double Velour Graft	23	0	6.4%	55.8%
Gore Tag Thoracic Endoprosthesis	7	4	14.7%	3.3%
Jostent Graftmaster	2	0	23.5%	8.2%
Advanta V12 Covered Stent	1	0	12.6%	37.9%
Asku	1	210	1.1%	47.1%
GORE EXCLUDER AAA Endoprosthesis	1	633	4.8%	7%
Zenith Aaa Main Body Graft	1	0	3.2%	2.1%

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."

Manufacturers named

Manufacturer (as written on reports)	Reports	Share
W L Gore & Associates	1,483	28.6%
Atrium Medical	349	6.7%
Cryolife	288	5.5%
Bard Peripheral Vascular	195	3.8%
Maquet Cardiovascular	130	2.5%
Merit Medical Systems	84	1.6%
Thoratec	76	1.5%
Baxter Healthcare	70	1.3%
Lemaitre Vascular	46	0.9%
Maquet Cv	19	0.4%
Edwards Lifesciences	4	0.1%
Terumo	3	0.1%
Cordis Europa	2	0%
Guidant Endovascular Solutions	2	0%
Maquet	2	0%

Reports by month, five years

FDA releases MAUDE data monthly; reports can arrive months after an event, so the newest months grow in later releases.

Event type and report source

Event type

Death7.2%375

Injury63.8%3,314

Malfunction20%1,037

Other6.4%334

Not given2.6%133

Who filed

Manufacturer report93.1%4,837

Voluntary report2%104

User facility report0%0

Distributor report2.1%109

Not given2.8%143

Grey bar: all 26,136,888 MAUDE reports.

Device problems coded

Device problem (FDA code)	Reports	Share
Insufficient device problem information	606	11.7%
Device remains implanted	455	8.8%
Occlusion within devicethe device blocked	429	8.3%
Leak/splashthe device leaked	415	8%
Explanted	350	6.7%
Replace	226	4.4%
Peeled/delaminated	203	3.9%
Device operates differently than expectedthe device behaved unexpectedly	179	3.4%
Manufacturing, packaging or shipping problem	150	2.9%
Fluid/blood leak	143	2.8%
Obstruction of flow	138	2.7%
Tears, rips, holes in device, device material	137	2.6%
Other (for use when an appropriate device code cannot be identified)	127	2.4%
Torn material	97	1.9%
Material split, cut or torn	89	1.7%
Material separation	88	1.7%
Complete blockage	86	1.7%
Material integrity problema problem with the device material	77	1.5%
Patient-device incompatibilitythe device did not suit the patient	74	1.4%
Material rupture	70	1.3%

Questions about prosthesis, vascular graft, of 6mm and greater diameter reports

What is product code DSY?

FDA's classification code for "Prosthesis, vascular graft, of 6mm and greater diameter", class 2, reviewed by the cardiovascular panel. Every device report carries the product code of the device involved.

How many reports carry this code?

5,193 reports through August 2026, 209 of them in the latest 12 months.

Which brands appear most often?

Gore Propaten Vascular Graft (505), Hero Graft (441), GORE ACUSEAL Vascular Graft (338), Gore Hybrid Vascular Graft (155) and Gore-Tex Stretch Vascular Graft (155). Widely used products collect more reports because more people use them.

Can the brands table be used to rank the devices?

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." Brands differ in how many are in use, how long they have been sold and how reports are collected.

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. 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.