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2026 data FDA MAUDE openFDA FDA Class II

Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

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 §870.1250 (Cardiovascular panel).

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FDA MAUDE casebook

openFDA event book Temporary Coronary Saphenous Vein Bypass Gr… LIGHT-BOOK · MAUDE

#497 of 1000 · 2,032 reports · 2001–2026

  • BOOK 2,032 reports
  • RANK #497 of 1000
  • DEATH 38 death-typed
  • INJ 777 injury-typed
  • MALF 1,189 malfunction
  • SPAN 2001–2026
  • PEAK 2005: 196
  • PHOTO Tricuspid Valve Repai…

Nearest event-volume peer: Tricuspid Valve Repair Device, Percutaneously Delivered (4 report gap)

Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection sits #497 of 1000 among tracked device types with 2,032 MAUDE reports spanning 2001–2026. 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 →

Injury-coded reports run above the device-type norm

Temporary Coronary Saphenous Vein Bypass Gr… carries 38.2% INJURY-coded reports, 7.9pp above the 1,000-device-type mean, the widest gap of its three event codes. Codes are report labels, not adjudicated causation.

  • DEATH 1.9% corpus 1.5% · near corpus mean (+0.4 pp)
  • INJ 38.2% corpus 30.3% · above corpus mean (+7.9 pp)
  • MALF 58.5% corpus 64.8% · below corpus mean (-6.3 pp)

Lead product-problem code Difficult to Remove is 16% of coded problems · Lead manufacturer BOSTON SCIENTIFIC CORPORATION accounts for 33% of manufacturer-tagged reports · Top event location is 37% of location-tagged rows .

Temporary Coronary Saphenous Vein Bypass Gr… in the event-volume neighbourhood

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

reports

What this shows Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection carries 2,032 MAUDE reports, ranked #497 of 1000.

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

Event Types

Malfunction 1,189 (58.5%)
Injury 777 (38.2%)
Death 38 (1.9%)
26 (1.3%)
Other 2 (0.1%)

Patient Outcomes

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

1,195 (53.5%)
Required Intervention 436 (19.5%)
Other 169 (7.6%)
Hospitalization 142 (6.4%)
R 91 (4.1%)
S 83 (3.7%)
Death 37 (1.7%)
Disability 37 (1.7%)
L 14 (0.6%)
O 14 (0.6%)
Life Threatening 13 (0.6%)
H 4 (0.2%)

Top Product Problems

Difficult to Remove 379
Deflation, cause unknown 269
Adverse Event Without Identified Device or Use Problem 216
Deflation Problem 199
Replace 196
Device, removal of (non-implant) 151
Unknown (for use when the device problem is not known) 125
Material Integrity Problem 111
Break 91
Failure to Advance 85
Material Separation 82
Detachment of Device or Device Component 79
Other (for use when an appropriate device code cannot be identified) 74
Kinked 58
Detachment Of Device Component 52
Physical Resistance 50
Sticking 49
Inflation Problem 48
Difficult or Delayed Positioning 42
Wire(s), breakage of 39

Yearly Trend

01
2001: 78
02
2002: 143
03
2003: 123
04
2004: 97
05
2005: 196
06
2006: 188
07
2007: 110
08
2008: 80
09
2009: 104
10
2010: 183
11
2011: 45
12
2012: 55
13
2013: 48
14
2014: 42
15
2015: 41
16
2016: 63
17
2017: 50
18
2018: 78
19
2019: 40
20
2020: 20
21
2021: 25
22
2022: 23
23
2023: 22
24
2024: 55
25
2025: 92
26
2026: 31

Reports rose to 92 in 2025, up from an average of 39 in the two years before - a recent-year increase, not a lifetime pattern.

Related Entities for Temporary Coronary Saphenous Vein Bypass Graft For Embolic Protection

Top Manufacturers

BOSTON SCIENTIFIC CORPORATION 305
MEDTRONIC, INC. 213
MEDTRONIC INC. 130
COVIDIEN 125
BOSTON SCIENTIFIC 115
BOSTON SCIENTIFIC - COSTA RICA (COYOL) 50

Event Locations

745 (36.7%)
HOSPITAL 679 (33.4%)
I 286 (14.1%)
UNKNOWN 263 (12.9%)
OTHER 43 (2.1%)
NO INFORMATION 10 (0.5%)
NOT APPLICABLE 4 (0.2%)
AMBULATORY SURGICAL FACILITY 1 (0.0%)
OUTPATIENT DIAGNOSTIC FACILITY 1 (0.0%)

Compare BOSTON SCIENTIFIC CORPORATION vs MEDTRONIC, INC. →

Nationwide devices with a comparable volume-and-death footprint

Two openFDA-derived peer sets for Temporary Coronary Saphenous Vein Bypass Gr…: 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 (2,032 here).

Tricuspid Valve Repair Device 2,028 Apparatus 2,026 Pouch, Colostomy 2,020 Valve, Pulmonary 2,016

Similar death-typed counts

Nearest other device types by death-typed report count (38 here), distinct from the volume row.

Airway, Oropharyngeal, Anesthesiology 39 Suture 39 System 39 System, Nuclear Magnetic Resonance Imaging 37

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

Disclaimer: MAUDE figures for Temporary Coronary Saphenous Vein Bypass Gr… 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 Temporary Coronary Saphenous Vein Bypass Gr…; 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.