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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 7

MDR Year MDR Reports MDR Events
2019 2820 2820
2020 2466 2466
2021 2833 2833
2022 2566 2566
2023 3495 3495
2024 2311 2311

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 7012 7012
Gradient Increase 5569 5569
Degraded 2674 2674
Fluid/Blood Leak 2376 2376
Calcified 2021 2021
Adverse Event Without Identified Device or Use Problem 1883 1883
Appropriate Term/Code Not Available 1151 1151
Device Stenosis 964 964
Incomplete Coaptation 805 805
Patient Device Interaction Problem 703 703
Difficult to Open or Close 566 566
Perivalvular Leak 527 527
Central Regurgitation 435 435
Material Split, Cut or Torn 215 215
Structural Problem 171 171
Inadequacy of Device Shape and/or Size 147 147
Patient-Device Incompatibility 105 105
Detachment of Device or Device Component 74 74
Therapeutic or Diagnostic Output Failure 68 68
Thickening of Material 62 62
Obstruction of Flow 61 61
Unintended Movement 49 49
Leak/Splash 35 35
Break 34 34
Entrapment of Device 30 30
Material Separation 28 28
Material Deformation 28 28
Off-Label Use 26 26
Mechanical Jam 24 24
Fracture 18 18
Microbial Contamination of Device 18 18
Material Puncture/Hole 17 17
Material Perforation 17 17
Naturally Worn 17 17
Material Integrity Problem 16 16
Defective Device 16 16
Contamination /Decontamination Problem 13 13
Material Too Rigid or Stiff 12 12
Malposition of Device 11 11
Mechanical Problem 10 10
Partial Blockage 10 10
Backflow 10 10
No Apparent Adverse Event 8 8
Physical Resistance/Sticking 7 7
Pitted 7 7
Defective Component 7 7
Positioning Problem 7 7
Material Twisted/Bent 6 6
Contamination 6 6
Particulates 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 6869 6869
Aortic Valve Stenosis 3230 3233
Heart Failure/Congestive Heart Failure 2393 2393
Dyspnea 2113 2114
Mitral Valve Stenosis 1095 1099
Aortic Regurgitation 1061 1061
Aortic Valve Insufficiency/ Regurgitation 1029 1029
Stenosis 957 957
No Known Impact Or Consequence To Patient 719 719
Regurgitation 653 653
Mitral Regurgitation 648 651
No Information 561 561
Endocarditis 444 444
Fatigue 322 322
Calcium Deposits/Calcification 304 307
Aortic Insufficiency 296 296
No Code Available 262 262
Chest Pain 246 247
No Clinical Signs, Symptoms or Conditions 228 228
Pulmonary Valve Stenosis 196 196
Failure of Implant 173 173
Congestive Heart Failure 159 160
Non specific EKG/ECG Changes 149 149
Mitral Valve Insufficiency/ Regurgitation 143 143
Pulmonary Regurgitation 132 133
Dizziness 132 132
Death 118 118
Tricuspid Valve Stenosis 116 116
Syncope/Fainting 111 111
Atrial Fibrillation 110 110
Cardiogenic Shock 106 106
Hemorrhage/Bleeding 105 105
Corneal Pannus 95 95
Thrombosis/Thrombus 89 89
Tricuspid Regurgitation 84 84
Heart Block 79 79
Cusp Tear 79 79
Stroke/CVA 76 76
Swelling/ Edema 69 69
Regurgitation, Valvular 65 65
Thrombus 64 69
Valvular Insufficiency/ Regurgitation 63 63
Insufficiency, Valvular 56 56
Heart Failure 53 53
Thrombosis 50 50
Cardiac Arrest 43 44
Unspecified Infection 42 42
Complete Heart Block 37 37
Pulmonary Valve Insufficiency/ Regurgitation 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37

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