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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device system, laser, transmyocardial revascularization
Product CodeMNO
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
2 1 1 5 1 3 2 3 4 1 1 0 1 1 0 0

MDR Year MDR Reports MDR Events
2014 27 27
2015 14 14
2016 6 6
2017 11 11
2018 10 10
2019 2 2
2022 2 2

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 20 20
Adverse Event Without Identified Device or Use Problem 19 19
Break 8 8
Device Operates Differently Than Expected 6 6
Loss of Power 3 3
Material Separation 3 3
Device Inoperable 2 2
Device Displays Incorrect Message 2 2
Difficult to Advance 2 2
Crack 2 2
Appropriate Term/Code Not Available 2 2
Material Frayed 1 1
Device Maintenance Issue 1 1
Difficult To Position 1 1
Thermal Decomposition of Device 1 1
Calibration Error 1 1
Charred 1 1
Detachment Of Device Component 1 1
Component Falling 1 1
Bent 1 1
Failure to Fire 1 1
Detachment of Device or Device Component 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 13 13
Atrial Fibrillation 11 11
No Consequences Or Impact To Patient 11 11
Angina 10 10
Arrhythmia 4 4
Chest Pain 3 3
Congestive Heart Failure 3 3
Death 3 3
Dyspnea 3 3
Hemorrhage/Bleeding 3 3
No Patient Involvement 3 3
No Information 3 3
No Code Available 3 3
No Clinical Signs, Symptoms or Conditions 2 2
Bradycardia 1 1
Unspecified Infection 1 1
Myocardial Infarction 1 1
Pleural Effusion 1 1
Ventricle, Abnormality Of 1 1
Swelling 1 1
Tachycardia 1 1
Ventricular Tachycardia 1 1
Dizziness 1 1
Failure to Anastomose 1 1
Syncope 1 1
Anemia 1 1
Heart Failure 1 1
Stenosis 1 1
Therapeutic Response, Decreased 1 1
Post Operative Wound Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Cardiogenesis Corporation II Sep-11-2013
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