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2026 data FDA MAUDE openFDA

Graft, Vascular, Synthetic/Biologic Composite

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.

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FDA MAUDE casebook

openFDA event book Graft LIGHT-BOOK · MAUDE

#685 of 1000 · 870 reports · 1996–2026

  • BOOK 870 reports
  • RANK #685 of 1000
  • DEATH 43 death-typed
  • INJ 374 injury-typed
  • MALF 449 malfunction
  • SPAN 1996–2026
  • PEAK 1997: 83
  • PHOTO Condylar Plate Fixati…

Nearest event-volume peer: Condylar Plate Fixation Implant (2 report gap)

Graft, Vascular, Synthetic/Biologic Composite sits #685 of 1000 among tracked device types with 870 MAUDE reports spanning 1996–2026. 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 4.9% corpus 1.5% · above corpus mean (+3.4 pp)
  • INJ 43.0% corpus 30.4% · above corpus mean (+12.5 pp)
  • MALF 51.6% corpus 64.5% · below corpus mean (-12.9 pp)

Lead product-problem code Adverse Event Without Identified Device or Use Problem is 11% of coded problems · Lead manufacturer MAQUET CARDIOVASCULAR, LLC accounts for 60% of manufacturer-tagged reports · Top event location HOSPITAL is 64% of location-tagged rows .

Graft in the event-volume neighbourhood

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

reports

What this shows Graft, Vascular, Synthetic/Biologic Composite carries 870 MAUDE reports, ranked #685 of 1000.

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

Event Types

Malfunction 449 (51.6%)
Injury 374 (43.0%)
Death 43 (4.9%)
Other 3 (0.3%)
1 (0.1%)

Patient Outcomes

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

Other 441 (43.8%)
179 (17.8%)
Required Intervention 116 (11.5%)
Hospitalization 83 (8.2%)
R 77 (7.6%)
Death 43 (4.3%)
O 35 (3.5%)
L 15 (1.5%)
S 9 (0.9%)
Life Threatening 8 (0.8%)
Disability 2 (0.2%)

Top Product Problems

Adverse Event Without Identified Device or Use Problem 24
Manufacturing, Packaging or Shipping Problem 23
Product Quality Problem 23
Material Frayed 22
Off-Label Use 21
Material Puncture/Hole 17
Nonstandard Device 16
Leak/Splash 11
Material Integrity Problem 9
Device Contaminated During Manufacture or Shipping 7
Device Damaged Prior to Use 7
Improper or Incorrect Procedure or Method 6
Device Operates Differently Than Expected 5
Fluid/Blood Leak 5
Hole In Material 5
Patient Device Interaction Problem 5
Shipping Damage or Problem 5
Flaked 4
Inaccurate Information 4
Insufficient Information 4

Yearly Trend

96
1996: 55
97
1997: 83
98
1998: 54
99
1999: 59
00
2000: 49
01
2001: 28
02
2002: 33
03
2003: 40
04
2004: 29
05
2005: 31
06
2006: 30
07
2007: 14
08
2008: 12
09
2009: 5
10
2010: 7
11
2011: 13
12
2012: 14
13
2013: 34
14
2014: 24
15
2015: 29
16
2016: 20
17
2017: 28
18
2018: 15
19
2019: 28
20
2020: 24
21
2021: 34
22
2022: 21
23
2023: 16
24
2024: 10
25
2025: 28
26
2026: 3

Related Entities for Graft, Vascular, Synthetic/Biologic Composite

Top Manufacturers

MAQUET CARDIOVASCULAR, LLC 81
MAQUET CARDIOVASCULAR LLC 22
BOSTON SCIENTIFIC CORPORATION 17
MAQUET CV 16

Event Locations

HOSPITAL 556 (63.9%)
155 (17.8%)
I 116 (13.3%)
HOME 18 (2.1%)
NO INFORMATION 10 (1.1%)
OUTPATIENT DIAGNOSTIC FACILITY 6 (0.7%)
INVALID DATA 4 (0.5%)
OTHER 4 (0.5%)
UNKNOWN 1 (0.1%)

Compare MAQUET CARDIOVASCULAR, LLC vs MAQUET CARDIOVASCULAR LLC →

Nationwide devices with similar MAUDE profiles

Two openFDA-derived peer sets for Graft, 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 (870 here).

Condylar Plate Fixation Implant 868 Culture Media 866 Suture 874 Recorder, Magnetic Tape, Medical 862

Similar death-typed counts

Nearest other device types by death-typed report count (43 here), distinct from the volume row.

Bath, Hydro-Massage 43 Catheter, Peritoneal, Long-Term Indwelling 44 Catheters, Suction, Tracheobronchial 42 Filler, Bone Void, Calcium Compound 44

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

Disclaimer: MAUDE figures for Graft 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 Graft; 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.