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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)
2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
13 22 34 27 16 13 7 8 11 2

MDR Year MDR Reports MDR Events
2015 1240 1240
2016 1744 1744
2017 2284 2284
2018 3166 3166
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 10589 10589
Gradient Increase 5813 5813
Degraded 3812 3812
Calcified 3128 3128
Adverse Event Without Identified Device or Use Problem 2498 2498
Appropriate Term/Code Not Available 2410 2410
Fluid/Blood Leak 2384 2384
Incomplete Coaptation 1612 1612
Perivalvular Leak 953 953
Patient Device Interaction Problem 584 584
Difficult to Open or Close 580 580
Device Stenosis 501 501
Structural Problem 294 294
Central Regurgitation 247 247
Material Split, Cut or Torn 213 213
Inadequacy of Device Shape and/or Size 209 209
Patient-Device Incompatibility 159 159
Leak/Splash 156 156
Obstruction of Flow 89 89
Torn Material 88 88
Restricted Flow rate 88 88
Detachment of Device or Device Component 80 80
Unintended Movement 78 78
Material Deformation 72 72
Therapeutic or Diagnostic Output Failure 70 70
Defective Device 66 66
Protective Measures Problem 58 58
Naturally Worn 46 46
Thickening of Material 39 39
Material Separation 36 36
Fracture 35 35
Material Too Rigid or Stiff 33 33
Break 31 31
Entrapment of Device 28 28
Off-Label Use 26 26
Occlusion Within Device 26 26
Material Integrity Problem 24 24
Malposition of Device 22 22
Device Operates Differently Than Expected 22 22
Material Perforation 21 21
Material Puncture/Hole 19 19
No Apparent Adverse Event 18 18
Mechanical Jam 17 17
Backflow 17 17
Microbial Contamination of Device 16 16
Defective Component 15 15
Mechanical Problem 15 15
Contamination /Decontamination Problem 14 14
Device Dislodged or Dislocated 11 11
Compatibility Problem 11 11
Particulates 11 11
Partial Blockage 11 11
Hole In Material 10 10
Activation, Positioning or Separation Problem 10 10
Improper Flow or Infusion 9 9
Positioning Problem 9 9
Contamination 9 9
Output Problem 8 8
Material Twisted/Bent 8 8
Physical Resistance/Sticking 8 8
Pitted 7 7
Migration or Expulsion of Device 7 7
Improper or Incorrect Procedure or Method 7 7
Material Rupture 6 6
Reflux within Device 6 6
Difficult to Fold, Unfold or Collapse 6 6
Material Distortion 5 5
Device Contamination with Chemical or Other Material 5 5
Manufacturing, Packaging or Shipping Problem 5 5
Device Damaged by Another Device 5 5
Folded 5 5
Separation Problem 5 5
Tear, Rip or Hole in Device Packaging 4 4
Biocompatibility 4 4
Device Markings/Labelling Problem 4 4
Material Protrusion/Extrusion 4 4
Retraction Problem 4 4
Device Inoperable 4 4
Device Abrasion From Instrument Or Another Object 4 4
Detachment Of Device Component 3 3
Unraveled Material 3 3
Loose or Intermittent Connection 3 3
Burst Container or Vessel 3 3
Difficult or Delayed Positioning 3 3
Material Discolored 3 3
Infusion or Flow Problem 3 3
Sediment, Precipitate Or Deposit In Device Or Device Ingredient 3 3
Use of Device Problem 3 3
Missing Information 3 3
Delivery System Failure 2 2
Deformation Due to Compressive Stress 2 2
Connection Problem 2 2
Escape 2 2
Device-Device Incompatibility 2 2
Difficult to Advance 2 2
Packaging Problem 2 2
Pressure Problem 2 2
Activation Failure 2 2
Incorrect Device Or Component Shipped 2 2
Disconnection 2 2

Patient Problems MDRs with this Patient Problem Events in those MDRs
Aortic Valve Stenosis 6528 6533
Insufficient Information 6006 6006
Aortic Regurgitation 2691 2692
No Information 2385 2385
Mitral Valve Stenosis 2363 2369
Heart Failure/Congestive Heart Failure 2148 2148
Dyspnea 1883 1884
Mitral Regurgitation 1531 1536
Stenosis 1355 1355
Aortic Valve Insufficiency/ Regurgitation 923 923
Regurgitation 896 897
No Known Impact Or Consequence To Patient 893 893
Aortic Insufficiency 687 687
Endocarditis 642 642
No Code Available 642 642
Calcium Deposits/Calcification 625 629
Pulmonary Valve Stenosis 352 352
Failure of Implant 306 315
Tricuspid Valve Stenosis 290 290
Fatigue 273 273
Pulmonary Regurgitation 272 273
Death 262 262
Tricuspid Regurgitation 258 258
Corneal Pannus 251 251
Congestive Heart Failure 220 221
Chest Pain 213 214
No Clinical Signs, Symptoms or Conditions 190 190
Hemorrhage/Bleeding 158 158
Cardiogenic Shock 143 143
Mitral Valve Insufficiency/ Regurgitation 137 137
Thrombosis 137 137
Non specific EKG/ECG Changes 132 132
Atrial Fibrillation 125 126
Thrombus 122 127
Dizziness 120 120
Regurgitation, Valvular 112 112
Syncope/Fainting 101 101
Heart Failure 94 94
Stroke/CVA 93 93
Complete Heart Block 84 84
Cusp Tear 84 84
Thrombosis/Thrombus 76 76
Insufficiency, Valvular 76 76
Mitral Insufficiency 76 76
Occlusion 72 72
Heart Block 72 72
Cardiac Arrest 68 69
Unspecified Infection 63 64
Obstruction/Occlusion 62 62
Valvular Insufficiency/ Regurgitation 59 59
Swelling/ Edema 53 53
Low Blood Pressure/ Hypotension 52 52
Patient Problem/Medical Problem 47 47
Rupture 44 44
Arrhythmia 44 44
Pulmonary Insufficiency 42 42
Myocardial Infarction 39 39
Valvular Stenosis 39 39
Abscess 37 37
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 35 35
Pulmonary Valve Insufficiency/ Regurgitation 35 35
Blood Loss 35 36
Aneurysm 33 33
Sepsis 33 33
High Blood Pressure/ Hypertension 32 32
Renal Failure 30 31
Thromboembolism 30 30
Low Cardiac Output 29 29
Bradycardia 29 29
Foreign Body Reaction 28 28
Angina 28 28
Fever 27 27
Pulmonary Edema 27 28
Pleural Effusion 27 27
Pulmonary Hypertension 25 25
Peripheral Edema 24 24
Organ Dehiscence 24 24
Respiratory Failure 24 24
Hematoma 24 24
Tachycardia 23 23
Pseudoaneurysm 23 23
Host-Tissue Reaction 21 21
Bacterial Infection 20 20
Edema 20 20
Pericardial Effusion 20 20
Hemolytic Anemia 20 20
Presyncope 18 18
Vascular Dissection 17 17
Injury 17 17
Multiple Organ Failure 16 16
Hemolysis 16 16
Hypoxia 16 16
Anemia 15 15
Tricuspid Valve Insufficiency/ Regurgitation 15 15
Aortic Dissection 14 14
Cardiomyopathy 14 14
Ventricular Fibrillation 14 14
Wound Dehiscence 13 13
Tissue Damage 12 12
Transient Ischemic Attack 12 12

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