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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device replacement heart-valve
Definition Call for pmas to be filed by 12/9/87 (52 fr 23137 (6/17/87))
Product CodeDYE
Regulation Number 870.3925
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
16 13 7 8 11 5

MDR Year MDR Reports MDR Events
2019 2820 2820
2020 2466 2466
2021 2833 2833
2022 2566 2566
2023 3495 3495
2024 831 831

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 6405 6405
Gradient Increase 5498 5498
Degraded 2535 2535
Fluid/Blood Leak 2354 2354
Adverse Event Without Identified Device or Use Problem 1859 1859
Calcified 1847 1847
Appropriate Term/Code Not Available 1142 1142
Incomplete Coaptation 796 796
Patient Device Interaction Problem 578 578
Difficult to Open or Close 565 565
Perivalvular Leak 514 514
Device Stenosis 501 501
Central Regurgitation 247 247
Material Split, Cut or Torn 200 200
Structural Problem 171 171
Inadequacy of Device Shape and/or Size 127 127
Patient-Device Incompatibility 103 103
Detachment of Device or Device Component 74 74
Therapeutic or Diagnostic Output Failure 68 68
Obstruction of Flow 61 61
Unintended Movement 49 49
Thickening of Material 39 39
Leak/Splash 35 35
Material Separation 28 28
Material Deformation 28 28
Entrapment of Device 27 27
Off-Label Use 26 26
Break 22 22
Fracture 18 18
Material Puncture/Hole 17 17
Material Perforation 17 17
Mechanical Jam 17 17
Naturally Worn 17 17
Defective Device 16 16
Material Integrity Problem 15 15
Microbial Contamination of Device 14 14
Contamination /Decontamination Problem 12 12
Material Too Rigid or Stiff 12 12
Malposition of Device 11 11
Backflow 10 10
Partial Blockage 10 10
Mechanical Problem 8 8
No Apparent Adverse Event 8 8
Positioning Problem 7 7
Physical Resistance/Sticking 7 7
Pitted 7 7
Defective Component 7 7
Particulates 6 6
Contamination 6 6
Material Twisted/Bent 6 6
Protective Measures Problem 6 6
Separation Problem 5 5
Migration or Expulsion of Device 5 5
Reflux within Device 5 5
Material Rupture 4 4
Device Dislodged or Dislocated 4 4
Device Contamination with Chemical or Other Material 3 3
Improper Flow or Infusion 3 3
Material Protrusion/Extrusion 3 3
Missing Information 3 3
Unraveled Material 3 3
Improper or Incorrect Procedure or Method 3 3
Biocompatibility 3 3
Device Damaged by Another Device 3 3
Device-Device Incompatibility 2 2
Difficult to Advance 2 2
Device Markings/Labelling Problem 2 2
Activation, Positioning or Separation Problem 2 2
Use of Device Problem 2 2
Material Invagination 2 2
Delivered as Unsterile Product 2 2
Restricted Flow rate 2 2
Compatibility Problem 2 2
Manufacturing, Packaging or Shipping Problem 2 2
Packaging Problem 2 2
Pressure Problem 1 1
Activation Failure 1 1
Premature Separation 1 1
Incomplete or Inadequate Connection 1 1
Activation Problem 1 1
Firing Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Infusion or Flow Problem 1 1
Gas/Air Leak 1 1
Measurement System Incompatibility 1 1
Mechanics Altered 1 1
Output Problem 1 1
Inaccurate Flow Rate 1 1
Material Erosion 1 1
Flaked 1 1
Crack 1 1
Difficult or Delayed Positioning 1 1
Disconnection 1 1
Premature Discharge of Battery 1 1
Complete Blockage 1 1
Coagulation in Device or Device Ingredient 1 1
Collapse 1 1
Unsealed Device Packaging 1 1
Product Quality Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 6001 6001
Aortic Valve Stenosis 3121 3124
Heart Failure/Congestive Heart Failure 2147 2147
Dyspnea 1790 1791
Mitral Valve Stenosis 1088 1092
Aortic Regurgitation 1061 1061
Stenosis 953 953
Aortic Valve Insufficiency/ Regurgitation 922 922
No Known Impact Or Consequence To Patient 719 719
Regurgitation 653 653
Mitral Regurgitation 648 651
No Information 561 561
Endocarditis 414 414
Calcium Deposits/Calcification 298 301
Aortic Insufficiency 296 296
No Code Available 262 262
Fatigue 261 261
Chest Pain 208 209
Pulmonary Valve Stenosis 192 192
No Clinical Signs, Symptoms or Conditions 189 189
Failure of Implant 170 170
Congestive Heart Failure 159 160
Mitral Valve Insufficiency/ Regurgitation 137 137
Pulmonary Regurgitation 132 133
Non specific EKG/ECG Changes 123 123
Death 118 118
Dizziness 118 118
Tricuspid Valve Stenosis 114 114
Hemorrhage/Bleeding 104 104
Syncope/Fainting 101 101
Cardiogenic Shock 100 100
Atrial Fibrillation 99 99
Corneal Pannus 94 94
Tricuspid Regurgitation 84 84
Thrombosis/Thrombus 76 76
Stroke/CVA 75 75
Cusp Tear 73 73
Heart Block 72 72
Regurgitation, Valvular 65 65
Thrombus 64 69
Valvular Insufficiency/ Regurgitation 59 59
Insufficiency, Valvular 56 56
Heart Failure 53 53
Swelling/ Edema 53 53
Thrombosis 50 50
Unspecified Infection 41 41
Cardiac Arrest 39 40
Complete Heart Block 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Pulmonary Valve Insufficiency/ Regurgitation 35 35
Low Blood Pressure/ Hypotension 34 34
Mitral Insufficiency 31 31
Obstruction/Occlusion 30 30
Sepsis 28 28
Foreign Body Reaction 28 28
Pulmonary Hypertension 25 25
Peripheral Edema 24 24
Blood Loss 24 24
Rupture 24 24
Myocardial Infarction 24 24
Pulmonary Insufficiency 24 24
Low Cardiac Output 23 23
Pleural Effusion 22 22
High Blood Pressure/ Hypertension 22 22
Abscess 22 22
Renal Failure 21 21
Occlusion 20 20
Tachycardia 20 20
Angina 20 20
Bradycardia 19 19
Pulmonary Edema 19 19
Valvular Stenosis 19 19
Presyncope 18 18
Thromboembolism 18 18
Organ Dehiscence 18 18
Aneurysm 18 18
Arrhythmia 18 18
Hematoma 17 17
Fever 17 17
Respiratory Failure 17 17
Pericardial Effusion 17 17
Host-Tissue Reaction 16 16
Vascular Dissection 15 15
Pseudoaneurysm 15 15
Tricuspid Valve Insufficiency/ Regurgitation 15 15
Hypoxia 13 13
Wound Dehiscence 12 12
Bacterial Infection 11 11
Patient Problem/Medical Problem 11 11
Hemolytic Anemia 11 11
Transient Ischemic Attack 10 10
Ventricular Fibrillation 9 9
Tissue Damage 9 9
Pneumonia 9 9
Cardiomyopathy 9 9
Anemia 9 9
Cardiac Tamponade 8 8
Multiple Organ Failure 8 8
Cough 8 8
Malaise 7 7

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Inc II Jun-26-2019
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