PlainHospital

AV-TEMECULA-CT

Manufacturer adverse-event records for AV-TEMECULA-CT 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 · 2008–2019 · heavy-book · elevated Death-code · injury-heavy

Death-code intensity

AV-TEMECULA-CT carries an elevated Death-code share

Death-coded event_type rows are 2,495 of 77,603 (3.22% · elevated tercile among 434 manufacturers). Absolute volume is heavy-book.

What the Death-code reading shows for AV-TEMECULA-CT

The standout signal for AV-TEMECULA-CT is Death-code intensity: 3.22% of 77,603 reports (elevated tercile), while absolute volume is heavy-book.

As a heavy-book manufacturer, portfolio size and reporting obligations inflate absolute counts - pair AV-TEMECULA-CT with device-family pages before treating company totals as a safety verdict. Event_type Death and Injury are one code per report; Patient Outcomes below use a separate FDA population.

Reports span 20 device types, led in this extract by Injury at 48,755 (62.8% of event_type total). Peak single-year volume reaches 10,159 reports across 12 years. These are raw FDA submissions, not adjudicated findings. Snapshot . Verify current communications on the FDA MDR page.

77,603
Total Reports
2,495
Event-type Death
48,755
Injury Reports
20
Device Types

Event Types

Injury 48,755 (62.8%)
Malfunction 26,353 (34.0%)
Death 2,495 (3.2%)

Patient Outcomes

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

Required Intervention 38,607 (44.0%)
26,223 (29.9%)
Hospitalization 7,708 (8.8%)
R 7,220 (8.2%)
S 2,529 (2.9%)
Death 2,518 (2.9%)
Other 2,228 (2.5%)
Disability 253 (0.3%)
O 174 (0.2%)
L 101 (0.1%)
H 72 (0.1%)
Life Threatening 57 (0.1%)
Congenital Anomaly 9 (0.0%)
D 3 (0.0%)

Devices (20)

Device Reports
Device, Hemostasis, Vascular 28,402
Coronary Drug-Eluting Stent 17,022
Catheters, Transluminal Coronary Angioplasty, Percutaneous 8,562
Mitral Valve Repair Devices 5,911
Stent, Coronary 4,050
Wire, Guide, Catheter 3,207
Catheter, Angioplasty, Peripheral, Transluminal 2,737
Stent, Superficial Femoral Artery 1,189
Stent, Carotid 1,156
Catheter, Steerable 1,146
Stent, Iliac 955
Stents, Drains And Dilators For The Biliary Ducts 849
Temporary Carotid Catheter For Embolic Capture 674
Absorbable Coronary Drug-Eluting Stent 672
Syringe, Balloon Inflation 594
Stent, Renal 224
Adaptor, Stopcock, Manifold, Fitting, Cardiopulmonary Bypass 213
Introducer, Catheter 33
Catheter, Percutaneous 4
Intracranial Neurovascular Stent 2

Yearly Trend

08
2008: 2
09
2009: 4
10
2010: 210
11
2011: 8,844
12
2012: 8,279
13
2013: 8,408
14
2014: 8,575
15
2015: 8,029
16
2016: 9,425
17
2017: 10,159
18
2018: 10,087
19
2019: 5,581

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