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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heart-valve, mechanical
Product CodeLWQ
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
8 6 16 21 17 11 14 13 11 8 4 6 9 8 9 3

MDR Year MDR Reports MDR Events
2014 133 133
2015 139 139
2016 202 202
2017 298 298
2018 434 434
2019 350 350
2020 372 372
2021 287 287
2022 297 297
2023 455 455
2024 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 868 868
Insufficient Information 797 797
Incomplete Coaptation 203 203
Perivalvular Leak 184 184
Obstruction of Flow 163 163
Fracture 137 137
Inadequacy of Device Shape and/or Size 118 118
Physical Resistance/Sticking 106 106
Gradient Increase 98 98
Appropriate Term/Code Not Available 83 83
Biocompatibility 80 80
Detachment of Device or Device Component 73 73
Difficult to Open or Close 65 65
Patient Device Interaction Problem 60 60
Material Separation 56 56
Device Dislodged or Dislocated 54 54
Mechanical Jam 53 53
Device Operates Differently Than Expected 45 45
Patient-Device Incompatibility 42 42
Leak/Splash 40 40
Break 37 37
Backflow 28 28
No Apparent Adverse Event 17 17
Improper or Incorrect Procedure or Method 17 17
Microbial Contamination of Device 15 15
Device Stenosis 14 14
Calcified 13 13
Interference 12 12
Material Fragmentation 12 12
Detachment Of Device Component 12 12
Migration or Expulsion of Device 11 11
Structural Problem 11 11
Material Integrity Problem 10 10
Central Regurgitation 9 9
Material Split, Cut or Torn 9 9
Partial Blockage 9 9
Off-Label Use 9 9
Material Too Rigid or Stiff 8 8
Mechanical Problem 8 8
Defective Device 8 8
Device Markings/Labelling Problem 8 8
Degraded 8 8
Use of Device Problem 7 7
Positioning Problem 7 7
Device remains implanted 7 7
Sticking 7 7
Crack 6 6
Fluid/Blood Leak 5 5
Device Damaged by Another Device 5 5
Occlusion Within Device 5 5
Human-Device Interface Problem 4 4
Contamination 4 4
Defective Component 4 4
Device Handling Problem 4 4
Entrapment of Device 4 4
Noise, Audible 3 3
Difficult To Position 3 3
Product Quality Problem 3 3
Material Frayed 3 3
Difficult or Delayed Positioning 2 2
Unraveled Material 2 2
Contamination /Decontamination Problem 2 2
Component Missing 2 2
Missing Information 2 2
Material Disintegration 2 2
Shelf Life Exceeded 2 2
Torn Material 2 2
Separation Problem 2 2
Paravalvular leak(s) 2 2
Device Or Device Fragments Location Unknown 2 2
Pacing Problem 2 2
Impedance Problem 2 2
Malposition of Device 2 2
Component Falling 2 2
Scratched Material 2 2
Inadequate or Insufficient Training 2 2
Material Deformation 2 2
Device Contamination with Chemical or Other Material 2 2
Reflux within Device 1 1
Unintended Movement 1 1
Separation Failure 1 1
Patient Data Problem 1 1
Installation-Related Problem 1 1
Hole In Material 1 1
Insufficient Flow or Under Infusion 1 1
Mechanics Altered 1 1
Valve(s), sticking 1 1
Material Rupture 1 1
Material Erosion 1 1
Difficult to Insert 1 1
Improper Flow or Infusion 1 1
Device Expiration Issue 1 1
Material Perforation 1 1
Premature Activation 1 1
Packaging Problem 1 1
Pitted 1 1
Burst Container or Vessel 1 1
Gas/Air Leak 1 1
Measurement System Incompatibility 1 1
Escape 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 447 449
Insufficient Information 313 313
No Known Impact Or Consequence To Patient 233 233
Death 232 233
No Clinical Signs, Symptoms or Conditions 223 223
Endocarditis 208 208
Stroke/CVA 147 148
Hemorrhage/Bleeding 133 133
Thrombus 132 132
No Code Available 124 124
Dyspnea 97 97
Thrombosis/Thrombus 95 95
Aortic Valve Stenosis 94 94
Corneal Pannus 92 92
No Consequences Or Impact To Patient 87 87
Atrial Fibrillation 84 84
Thrombosis 79 79
Arrhythmia 67 67
Aortic Valve Insufficiency/ Regurgitation 67 67
Aortic Regurgitation 61 61
Heart Failure/Congestive Heart Failure 60 60
Thromboembolism 56 56
Mitral Regurgitation 56 56
Unspecified Infection 54 54
Aortic Insufficiency 53 53
Heart Block 47 47
Cardiac Arrest 43 43
Mitral Valve Stenosis 42 42
Valvular Insufficiency/ Regurgitation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Mitral Valve Insufficiency/ Regurgitation 35 35
Pericardial Effusion 35 35
Regurgitation 35 35
Myocardial Infarction 34 35
Non specific EKG/ECG Changes 33 33
Obstruction/Occlusion 31 31
Pseudoaneurysm 30 30
Pulmonary Edema 30 30
Renal Failure 30 30
Heart Failure 30 30
Embolism 27 28
Congestive Heart Failure 27 27
Hematoma 25 25
Hemolytic Anemia 24 24
Transient Ischemic Attack 24 24
Mitral Insufficiency 24 24
Low Cardiac Output 24 24
Insufficiency, Valvular 23 23
Tachycardia 23 23
Calcium Deposits/Calcification 23 23
Chest Pain 23 23
Anemia 23 23
Host-Tissue Reaction 22 22
Pleural Effusion 21 21
Cardiac Tamponade 21 21
Cardiogenic Shock 20 20
Ventricular Fibrillation 20 20
Sepsis 20 20
Aneurysm 20 20
Hemolysis 20 20
Complete Heart Block 20 20
Blood Loss 19 19
High Blood Pressure/ Hypertension 19 19
Stenosis 18 18
Regurgitation, Valvular 17 17
Low Blood Pressure/ Hypotension 17 17
Failure of Implant 15 15
Fatigue 15 15
Aortic Dissection 14 14
Complaint, Ill-Defined 14 14
Rupture 13 13
Pneumonia 13 13
Hypoxia 12 12
Abscess 12 12
Respiratory Insufficiency 12 12
Intracranial Hemorrhage 11 11
Occlusion 11 11
Foreign Body Reaction 10 10
Valvular Stenosis 10 10
Foreign Body In Patient 9 9
Hemoptysis 9 9
Bradycardia 9 9
Atrial Flutter 9 9
Bacterial Infection 9 9
Paresis 9 9
Septic Shock 8 8
Infarction, Cerebral 8 8
Fever 8 8
Respiratory Failure 8 8
Organ Dehiscence 8 8
Ischemia Stroke 8 8
Multiple Organ Failure 7 7
Angina 7 7
Syncope/Fainting 6 6
Cardiac Perforation 6 6
Vascular Dissection 5 5
Congenital Defect/Deformity 5 5
Cardiomyopathy 5 6
Pain 5 5
Left Ventricular Dysfunction 5 5

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Mar-28-2019
2 CryoLife, Inc. II Jul-12-2017
3 MEDTRONIC ATS MEDICAL, INC. II Mar-20-2020
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