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2026 data FDA MAUDE openFDA FDA Class II

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 Class II (moderate risk, special controls required), regulated under 21 CFR §870.3450 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Prosthesis LIGHT-BOOK · MAUDE

#312 of 1000 · 5,172 reports · 1992–2026

  • BOOK 5,172 reports
  • RANK #312 of 1000
  • DEATH 375 death-typed
  • INJ 3,304 injury-typed
  • MALF 1,026 malfunction
  • SPAN 1992–2026
  • PEAK 2015: 460
  • PHOTO Anesthesia Conduction…

Nearest event-volume peer: Anesthesia Conduction Kit (20 report gap)

Prosthesis, Vascular Graft, Of 6mm And Greater Diameter sits #312 of 1000 among tracked device types with 5,172 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 →

Malfunction reports sit below the device-type norm

Prosthesis carries 19.8% MALFUNCTION-coded reports, 45.0pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 7.3% corpus 1.5% · above corpus mean (+5.7 pp)
  • INJ 63.9% corpus 30.3% · above corpus mean (+33.6 pp)
  • MALF 19.8% corpus 64.8% · below corpus mean (-45.0 pp)

Lead product-problem code Insufficient Device Problem Information is 12% of coded problems · Lead manufacturer W.L. GORE & ASSOCIATES accounts for 52% of manufacturer-tagged reports · Top event location is 47% 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 5,172 MAUDE reports, ranked #312 of 1000.

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

Event Types

Injury 3,304 (63.9%)
Malfunction 1,026 (19.8%)
Death 375 (7.3%)
Other 334 (6.5%)
133 (2.6%)

Patient Outcomes

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

Required Intervention 2,323 (39.3%)
Other 960 (16.2%)
898 (15.2%)
Hospitalization 499 (8.4%)
R 432 (7.3%)
Death 387 (6.5%)
O 175 (3.0%)
Life Threatening 57 (1.0%)
H 53 (0.9%)
L 53 (0.9%)
Disability 37 (0.6%)
S 31 (0.5%)
Invalid Data 3 (0.1%)
D 2 (0.0%)

Top Product Problems

Insufficient Device Problem Information 603
Device remains implanted 455
Adverse Event Without Identified Device or Use Problem 434
Occlusion Within Device 430
Leak/Splash 414
Explanted 350
Unknown (for use when the device problem is not known) 278
Replace 227
Peeled/Delaminated 208
Appropriate Device Problem Term/Code Not Available 196
Device Operates Differently Than Expected 179
Manufacturing, Packaging or Shipping Problem 152
Fluid/Blood Leak 144
Obstruction of Flow 139
Tears, rips, holes in device, device material 137
Other (for use when an appropriate device code cannot be identified) 129
Torn Material 97
Material Separation 94
Material Split, Cut or Torn 90
Complete Blockage 89

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: 188
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: 138

Reports in 2025 (167) held close to the prior two-year average of 152.

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

Top Manufacturers

W.L. GORE & ASSOCIATES 884
W. L. GORE & ASSOCIATES, INC. 413
BARD PERIPHERAL VASCULAR, INC. 238
ATRIUM MEDICAL CORPORATION 166

Event Locations

2,407 (46.5%)
HOSPITAL 1,402 (27.1%)
I 1,238 (23.9%)
OTHER 50 (1.0%)
HOME 24 (0.5%)
INVALID DATA 18 (0.3%)
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 a comparable volume-and-death footprint

Two openFDA-derived peer sets for Prosthesis: nearest by total report volume and nearest by death-typed count, each floored at ≥100 reports so the neighborhoods stay in the advertised mass.

Similar report volume

Nearest other device types by FDA MAUDE report count (5,172 here).

Anesthesia Conduction Kit 5,152 Tissue Expander And Accessories 5,148 Prosthesis 5,146 Light, Surgical, Ceiling Mounted 5,203

Similar death-typed counts

Nearest other device types by death-typed report count (375 here), distinct from the volume row.

Mesh 376 Port & Catheter 373 Artificial Heart 368 Prosthesis, Hip, Semi-Constrained 387

Read our methodology - how this data is sourced, computed, and verified.

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.