System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment: medical device reports filed with FDA

2,762 reports carry this product code, 2014–2026; 8 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.

2,762
reports with this product code: 0% of all MAUDE reports; 269
reports, 12 months to August 2026: 175 in the 12 months before; 68.3%
classified as malfunction: 62.3% across all reports; 1.1%
classified as death, as reported: 0.9% across all reports

Product code PFV is FDA's classification for "System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment" (unknown panel), a class 3 device. 2,762 medical device reports carry this product code, 0% of the MAUDE database, from September 2014 to August 2026.

269 reports arrived in the 12 months to August 2026, up 54% from 175 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 malfunction (68.3%), injury (30.6%) and death (1.1%). 8 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
Fluency Plus Vascular Stent Graft	734	64	0.4%	92%
Fluency Plus Endovascular Stent Graft	635	35	0.6%	88.2%
Gore Viabahn Endoprosthesis - 3	353	0	3.1%	31.9%
Covera Vascular Covered Stent	338	42	0.3%	57.4%
GORE VIABAHN Endoprosthesis	164	18	5.8%	23.5%
GORE VIABAHN Endoprosthesis with HEPARIN Bioactive Surface	96	174	2.1%	50%
Flair Endovascular Stent Graft	56	0	0.3%	78.9%
GORE VIABAHN Endoprosthesis with PROPATEN Bioactive Surface	24	91	0.6%	40.5%

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
Angiomed & Medizintechnik Kg	1,492	54%
W L Gore & Associates	629	22.8%
Bard Peripheral Vascular	506	18.3%
Merit Medical Systems	89	3.2%
Bolton Medical	1	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

Death1.1%31

Injury30.6%845

Malfunction68.3%1,886

Other0%0

Not given0%0

Who filed

Manufacturer report99.4%2,745

Voluntary report0.3%7

User facility report0%0

Distributor report0%0

Not given0.4%10

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

Device problems coded

Device problem (FDA code)	Reports	Share
Positioning failure	868	31.4%
Misfire	836	30.3%
Fracturea broken bone	574	20.8%
Breakthe device broke	374	13.5%
Detachment of device or device componentpart of the device came off	188	6.8%
Material deformation	178	6.4%
Activation failure	169	6.1%
Material perforation	154	5.6%
Obstruction of flow	133	4.8%
Malposition of device	89	3.2%
Difficult to removethe device was hard to remove	85	3.1%
Difficult or delayed positioning	76	2.8%
Complete blockage	75	2.7%
Loss of or failure to bond	75	2.7%
Retraction problem	59	2.1%
Insufficient device problem information	47	1.7%
Patient-device incompatibilitythe device did not suit the patient	47	1.7%
Difficult to advance	45	1.6%
Positioning problem	44	1.6%
Activation, positioning or separation problem	39	1.4%

Questions about system, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment reports

What is product code PFV?

FDA's classification code for "System, endovascular graft, arteriovenous (av) dialysis access circuit stenosis treatment", class 3, reviewed by the unknown panel. Every device report carries the product code of the device involved.

How many reports carry this code?

2,762 reports through August 2026, 269 of them in the latest 12 months.

Which brands appear most often?

Fluency Plus Vascular Stent Graft (734), Fluency Plus Endovascular Stent Graft (635), Gore Viabahn Endoprosthesis - 3 (353), Covera Vascular Covered Stent (338) and GORE VIABAHN Endoprosthesis (164). 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.