2026 data FDA MAUDE openFDA

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Adverse-event figures are drawn from the U.S. Food & Drug Administration (FDA) MAUDE database, refreshed March 2026, see our methodology.

OpenFDA device adverse-event casebook.

FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#312 of 1000 · 5,047 reports · 1992–2026

  • BOOK 5,047 reports
  • RANK #312 of 1000
  • DEATH 372 death-typed
  • INJ 3,221 injury-typed
  • MALF 987 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 460
  • PHOTO Prosthesis

Nearest event-volume peer: Prosthesis, Knee, Femorotibial, Unicompartmental, Semi-Constrained, Metal/Polymer, Mobile Bearing (0 report gap)

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter sits #312 of 1000 among tracked device types with 5,047 MAUDE reports spanning 1992–2026. Rank counts report volume, not confirmed device fault. Event_type Death / Injury / Malfunction are one code per report — not the same population as patient-outcome rows ( methodology). Read with this device → · Lead manufacturer → · Similar-volume device →

Event-type mix vs corpus

Shares of FDA event_type codes on this device type, compared with the mean across 1,000 device types that have ≥100 MAUDE reports. Codes are report labels, not adjudicated causation.

  • DEATH 7.4% corpus 1.5% · above corpus mean (+5.9 pp)
  • INJ 63.8% corpus 30.4% · above corpus mean (+33.4 pp)
  • MALF 19.6% corpus 64.5% · below corpus mean (-45.0 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 15% of coded problems · Lead manufacturer W.L. GORE & ASSOCIATES accounts for 53% of manufacturer-tagged reports · Top event location is 45% of location-tagged rows .

Prosthesis in the event-volume neighbourhood

FDA MAUDE report totals among this device type and nearest nationwide peers

reports

What this shows Prosthesis, Vascular Graft, Of 6mm And Greater Diameter carries 5,047 MAUDE reports, ranked #312 of 1000.

Source FDA MAUDE via openFDA, aggregated by PlainHospital As of August 2026

Event Types

Injury 3,221 (63.8%)
Malfunction 987 (19.6%)
Death 372 (7.4%)
Other 334 (6.6%)
133 (2.6%)

Patient Outcomes

FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.

Required Intervention 2,267 (39.4%)
Other 940 (16.3%)
860 (14.9%)
Hospitalization 496 (8.6%)
R 419 (7.3%)
Death 384 (6.7%)
O 156 (2.7%)
Life Threatening 57 (1.0%)
H 53 (0.9%)
L 53 (0.9%)
Disability 35 (0.6%)
S 31 (0.5%)
Invalid Data 3 (0.1%)
D 2 (0.0%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 259
Insufficient Information 204
Peeled/Delaminated 167
Obstruction of Flow 109
Manufacturing, Packaging or Shipping Problem 97
Material Split, Cut or Torn 87
Material Integrity Problem 71
Patient-Device Incompatibility 65
Leak/Splash 62
Material Separation 61
Device Stenosis 57
Complete Blockage 56
Material Puncture/Hole 53
Occlusion Within Device 52
Product Quality Problem 51
Torn Material 49
Microbial Contamination of Device 46
Appropriate Term/Code Not Available 45
Device Operates Differently Than Expected 42
Contamination 40

Yearly Trend

92
1992: 4
93
1993: 7
94
1994: 25
95
1995: 11
96
1996: 42
97
1997: 148
98
1998: 128
99
1999: 109
00
2000: 130
01
2001: 90
02
2002: 102
03
2003: 121
04
2004: 94
05
2005: 107
06
2006: 85
07
2007: 120
08
2008: 164
09
2009: 193
10
2010: 187
11
2011: 165
12
2012: 177
13
2013: 207
14
2014: 352
15
2015: 460
16
2016: 217
17
2017: 193
18
2018: 200
19
2019: 232
20
2020: 169
21
2021: 168
22
2022: 155
23
2023: 149
24
2024: 155
25
2025: 167
26
2026: 14

Related Entities for Prosthesis, Vascular Graft, Of 6mm And Greater Diameter

Event Locations

2,290 (45.4%)
HOSPITAL 1,393 (27.6%)
I 1,239 (24.5%)
OTHER 50 (1.0%)
HOME 24 (0.5%)
INVALID DATA 18 (0.4%)
NO INFORMATION 12 (0.2%)
UNKNOWN 11 (0.2%)
AMBULATORY SURGICAL FACILITY 4 (0.1%)
NOT APPLICABLE 2 (0.0%)
OUTPATIENT TREATMENT FACILITY 2 (0.0%)
NURSING HOME 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare W.L. GORE & ASSOCIATES vs W. L. GORE & ASSOCIATES, INC. →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Prosthesis, both floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,047 here).

Similar death-typed counts

Nearest other device types by death-typed report count (372 here), distinct from the volume row.

Disclaimer: MAUDE figures for Prosthesis are informational only and are not clinical advice. Report codes do not prove device causation. Consult a qualified clinician before acting on this data.

Every figure on PlainHospital is rendered directly from federal source data, no number is typed in by an editor. Event-type mix on this page is computed from FDA MAUDE codes for Prosthesis; corpus means use device types with ≥100 reports. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of August 2026.