GUIDANT VASCULAR INTERVENTION

Manufacturer adverse-event records for GUIDANT VASCULAR INTERVENTION come from the U.S. Food & Drug Administration (FDA) MAUDE database via openFDA, refreshed March 2026 - see our methodology. Not medical advice.

FDA MAUDE device safety record · 1996–2007 · thin-book · elevated Death-code · injury-heavy

Volume signature

GUIDANT VASCULAR INTERVENTION is a thinner MAUDE footprint

GUIDANT VASCULAR INTERVENTION accounts for 4,011 FDA MAUDE reports (#417 of 434, thin-book tercile). Death-coded event_type share is 4.31% (elevated); Injury share 63.6% (injury-heavy).

What the volume reading shows for GUIDANT VASCULAR INTERVENTION

The standout signal for GUIDANT VASCULAR INTERVENTION is filing volume: 4,011 adverse-event reports in FDA MAUDE (#417 of 434, thin-book). Death-coded event_type share sits at 4.31% (elevated).

As a thinner-book manufacturer, a handful of device families can swing the totals; open the device table rather than reading the company headline alone. Event_type counts are not the same population as Patient Outcomes.

Reports span 20 device types, led in this extract by Injury at 2,552 (63.6% of event_type total). Peak single-year volume reaches 666 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

4,011
Total Reports
173
Event-type Death
2,552
Injury Reports
20
Device Types

Event Types

Injury 2,552 (63.6%)
Malfunction 1,268 (31.6%)
Death 173 (4.3%)
Other 18 (0.4%)

Patient Outcomes

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

Required Intervention 1,875 (38.7%)
1,271 (26.2%)
R 411 (8.5%)
Hospitalization 323 (6.7%)
S 319 (6.6%)
Disability 236 (4.9%)
Death 187 (3.9%)
Other 66 (1.4%)
L 64 (1.3%)
Life Threatening 57 (1.2%)
H 34 (0.7%)
O 2 (0.0%)
Congenital Anomaly 1 (0.0%)

Yearly Trend

96
1996: 1
97
1997: 2
98
1998: 145
99
1999: 403
00
2000: 318
01
2001: 384
02
2002: 473
03
2003: 459
04
2004: 472
05
2005: 490
06
2006: 666
07
2007: 198