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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 121 121

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 871 871
Insufficient Information 801 801
Incomplete Coaptation 209 209
Perivalvular Leak 185 185
Obstruction of Flow 163 163
Fracture 138 138
Inadequacy of Device Shape and/or Size 121 121
Physical Resistance/Sticking 111 111
Gradient Increase 98 98
Appropriate Term/Code Not Available 83 83
Biocompatibility 80 80
Detachment of Device or Device Component 73 73
Patient Device Interaction Problem 67 67
Difficult to Open or Close 65 65
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
Improper or Incorrect Procedure or Method 17 17
No Apparent Adverse Event 17 17
Device Stenosis 15 15
Microbial Contamination of Device 15 15
Calcified 13 13
Detachment Of Device Component 12 12
Material Fragmentation 12 12
Interference 12 12
Migration or Expulsion of Device 11 11
Structural Problem 11 11
Off-Label Use 10 10
Central Regurgitation 10 10
Material Split, Cut or Torn 10 10
Material Integrity Problem 10 10
Mechanical Problem 9 9
Degraded 9 9
Partial Blockage 9 9
Material Too Rigid or Stiff 8 8
Defective Device 8 8
Device Markings/Labelling Problem 8 8
Positioning Problem 7 7
Use of Device Problem 7 7
Sticking 7 7
Device remains implanted 7 7
Crack 6 6
Fluid/Blood Leak 5 5
Occlusion Within Device 5 5
Device Damaged by Another Device 5 5
Human-Device Interface Problem 4 4
Device Handling Problem 4 4
Contamination 4 4
Entrapment of Device 4 4
Defective Component 4 4
Product Quality Problem 3 3
Material Frayed 3 3
Difficult To Position 3 3
Noise, Audible 3 3
Material Deformation 2 2
Torn Material 2 2
Scratched Material 2 2
Impedance Problem 2 2
Device Contamination with Chemical or Other Material 2 2
Contamination /Decontamination Problem 2 2
Separation Problem 2 2
Missing Information 2 2
Pacing Problem 2 2
Paravalvular leak(s) 2 2
Difficult or Delayed Positioning 2 2
Material Disintegration 2 2
Component Falling 2 2
Inadequate or Insufficient Training 2 2
Shelf Life Exceeded 2 2
Device Or Device Fragments Location Unknown 2 2
Malposition of Device 2 2
Unraveled Material 2 2
Component Missing 2 2
Leaflet fracture 1 1
Insufficient Flow or Under Infusion 1 1
Material Perforation 1 1
Unstable 1 1
Valve(s), sticking 1 1
Separation Failure 1 1
Shipping Damage or Problem 1 1
Material Rupture 1 1
Failure to Sense 1 1
Device Inoperable 1 1
Reflux within Device 1 1
Difficult to Remove 1 1
Material Puncture/Hole 1 1
Pitted 1 1
Coagulation in Device or Device Ingredient 1 1
Burst Container or Vessel 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Unintended System Motion 1 1
Premature Activation 1 1
Device Difficult to Setup or Prepare 1 1
Increase in Pressure 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 447 449
Insufficient Information 324 324
No Known Impact Or Consequence To Patient 233 233
Death 232 233
No Clinical Signs, Symptoms or Conditions 228 228
Endocarditis 208 208
Stroke/CVA 147 148
Hemorrhage/Bleeding 134 134
Thrombus 132 132
No Code Available 124 124
Thrombosis/Thrombus 98 98
Dyspnea 98 98
Aortic Valve Stenosis 94 94
Corneal Pannus 92 92
No Consequences Or Impact To Patient 87 87
Atrial Fibrillation 84 84
Thrombosis 79 79
Aortic Valve Insufficiency/ Regurgitation 68 68
Arrhythmia 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 48 48
Cardiac Arrest 43 43
Mitral Valve Stenosis 42 42
Valvular Insufficiency/ Regurgitation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Mitral Valve Insufficiency/ Regurgitation 36 36
Non specific EKG/ECG Changes 36 36
Pericardial Effusion 35 35
Regurgitation 35 35
Obstruction/Occlusion 34 34
Myocardial Infarction 34 35
Pulmonary Edema 30 30
Renal Failure 30 30
Heart Failure 30 30
Pseudoaneurysm 30 30
Embolism 27 28
Congestive Heart Failure 27 27
Hematoma 25 25
Anemia 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
Chest Pain 23 23
Calcium Deposits/Calcification 23 23
Host-Tissue Reaction 22 22
Pleural Effusion 21 21
Cardiac Tamponade 21 21
Ventricular Fibrillation 20 20
Sepsis 20 20
Aneurysm 20 20
Hemolysis 20 20
Complete Heart Block 20 20
Cardiogenic Shock 20 20
Blood Loss 19 19
High Blood Pressure/ Hypertension 19 19
Stenosis 18 18
Low Blood Pressure/ Hypotension 17 17
Regurgitation, Valvular 17 17
Failure of Implant 15 15
Fatigue 15 15
Complaint, Ill-Defined 14 14
Aortic Dissection 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
Organ Dehiscence 8 8
Respiratory Failure 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
Unspecified Heart Problem 5 5
Congenital Defect/Deformity 5 5
Cardiomyopathy 5 6
Pain 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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