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.
FDA Class II (moderate risk, special controls required), regulated under 21 CFR §870.3450 (Cardiovascular panel).
FDA MAUDE casebook
openFDA event book Graft LIGHT-BOOK · MAUDE
#700 of 1000 · 878 reports · 1996–2026
- BOOK 878 reports
- RANK #700 of 1000
- DEATH 43 death-typed
- INJ 378 injury-typed
- MALF 453 malfunction
- SPAN 1996–2026
- PEAK 1997: 83
- PHOTO Culture Media
Nearest event-volume peer: Culture Media, Non-Selective And Non-Differential (1 report gap)
Graft, Vascular, Synthetic/Biologic Composite sits #700 of 1000 among tracked device types with 878 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 →
Malfunction reports sit below the device-type norm
Graft carries 51.6% MALFUNCTION-coded reports, 13.2pp below the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.
- DEATH 4.9% corpus 1.5% · above corpus mean (+3.4 pp)
- INJ 43.1% corpus 30.3% · above corpus mean (+12.8 pp)
- MALF 51.6% corpus 64.8% · below corpus mean (-13.2 pp)
Lead product-problem code Device remains implanted is 27% 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
- Accessories
Accessories, Catheter
886 reports
- Culture Media
Culture Media, Non-Selective And Non-Differential
879 reports
- Graft (this)
Graft, Vascular, Synthetic/Biologic Composite
878 reports
- Condylar Plat…
Condylar Plate Fixation Implant
876 reports
- Stent, Renal
Stent, Renal
874 reports
- Susceptibilit…
Susceptibility Test Powders, Antimycobacterial
874 reports
What this shows Graft, Vascular, Synthetic/Biologic Composite carries 878 MAUDE reports, ranked #700 of 1000.
Event Types
Patient Outcomes
FDA patient-outcome codes (separate from event_type). Percentages use this chart's row total.
Top Product Problems
Yearly Trend
Reports rose to 28 in 2025, up from an average of 13 in the two years before - a recent-year increase, not a lifetime pattern.
Related Entities for Graft, Vascular, Synthetic/Biologic Composite
Top Manufacturers
Event Locations
Compare MAQUET CARDIOVASCULAR, LLC vs MAQUET CARDIOVASCULAR LLC →
Nationwide devices with a comparable volume-and-death footprint
Two openFDA-derived peer sets for Graft: 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 (878 here).
Similar death-typed counts
Nearest other device types by death-typed report count (43 here), distinct from the volume row.
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.