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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device aortic valve, prosthesis, percutaneously delivered
Definition To replace a patient's aortic heart valve. They are different from the classified device (heart valves) in that they are placed percutaneously and do not require open chest surgery or a cardiotomy for placement.
Product CodeNPT
Device Class 3

Premarket Approvals (PMA)
2016 2017 2018 2019 2020 2021
61 65 43 59 48 12

MDR Year MDR Reports MDR Events
2016 2994 2994
2017 3115 3115
2018 3913 5377
2019 4362 9091
2020 5805 16015
2021 1441 4882

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 10525 19739
Perivalvular Leak 2985 2985
Device Dislodged or Dislocated 2353 2402
Insufficient Information 1551 12519
Malposition of Device 1323 1323
Burst Container or Vessel 710 710
Difficult to Remove 653 653
Fluid Leak 582 582
Gradient Increase 571 571
Appropriate Term/Code Not Available 506 529
Leak/Splash 484 484
Material Separation 471 471
Material Split, Cut or Torn 445 445
Material Rupture 436 436
Calcified 426 426
Migration or Expulsion of Device 355 365
Difficult to Advance 325 325
Degraded 318 318
Material Deformation 313 313
Activation Failure 305 305
Positioning Problem 304 530
Difficult or Delayed Positioning 288 288
Physical Resistance/Sticking 282 282
Incomplete Coaptation 236 236
Detachment of Device or Device Component 219 219
Torn Material 216 216
Failure to Advance 213 213
Migration 203 204
Inadequacy of Device Shape and/or Size 168 168
Inflation Problem 167 167
Material Twisted/Bent 161 161
Difficult to Insert 153 153
Activation, Positioning or SeparationProblem 140 140
Break 132 132
Unintended Movement 120 120
Peeled/Delaminated 92 92
Difficult To Position 88 88
Deformation Due to Compressive Stress 88 88
Entrapment of Device 81 81
Failure to Align 73 73
Obstruction of Flow 71 82
Patient-Device Incompatibility 67 67
Fracture 66 66
Positioning Failure 66 72
Material Puncture/Hole 65 65
Material Integrity Problem 65 65
No Apparent Adverse Event 58 58
Structural Problem 58 58
Inaccurate Delivery 56 56
Particulates 54 54
Material Invagination 51 51
Improper or Incorrect Procedure or Method 43 43
Difficult to Open or Close 39 39
Mechanical Problem 39 39
Retraction Problem 37 37
Deflation Problem 37 37
Therapeutic or Diagnostic Output Failure 36 36
Material Protrusion/Extrusion 35 35
Activation Problem 34 34
Device Operates Differently Than Expected 34 34
Material Fragmentation 31 31
Failure to Conduct 29 173
Split 29 29
Use of Device Problem 28 28
Difficult or Delayed Activation 27 27
Patient Device Interaction Problem 26 26
Physical Resistance 25 25
Defective Device 23 23
Mechanical Jam 20 20
Kinked 19 19
Device Slipped 18 18
Device-Device Incompatibility 17 17
Pacing Problem 17 143
Crack 16 16
Detachment Of Device Component 15 15
Separation Problem 15 15
Bent 13 13
Human-Device Interface Problem 13 13
Contamination /Decontamination Problem 13 13
Device Damaged by Another Device 12 12
Failure to Capture 12 12
Complete Blockage 12 12
Device Difficult to Setup or Prepare 12 12
Coagulation in Device or Device Ingredient 10 30
Device Contamination with Chemical or Other Material 10 10
Delamination 10 10
Incorrect, Inadequate or Imprecise Resultor Readings 9 9
Backflow 8 8
Separation Failure 8 8
Material Perforation 8 8
Component Missing 8 8
Noise, Audible 8 8
Packaging Problem 7 7
Folded 7 7
Hole In Material 7 7
Delivery System Failure 6 6
Microbial Contamination of Device 6 6
Device Damaged Prior to Use 5 5
Failure to Fire 5 5
Occlusion Within Device 5 5

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Known Impact Or Consequence To Patient 3226 3240
Complete Heart Block 3144 3146
Non specific EKG/ECG Changes 2208 2208
Aortic Regurgitation 1894 1923
Injury 1758 5086
Arrhythmia 1618 5245
Death 1528 2981
Stroke/CVA 1411 2422
No Consequences Or Impact To Patient 1226 1226
Rupture 985 987
Blood Loss 962 1117
Low Blood Pressure/ Hypotension 846 848
Vascular Dissection 804 985
No Code Available 800 904
Calcium Deposits/Calcification 775 777
Hemorrhage/Bleeding 711 1265
Occlusion 612 618
Infarction, Cerebral 567 947
Aortic Valve Stenosis 567 568
Myocardial Infarction 549 664
Vascular System (Circulation), Impaired 506 1588
Insufficiency, Valvular 434 434
Aortic Dissection 382 429
No Information 371 6343
Cardiac Tamponade 369 433
Atrial Fibrillation 358 358
Cardiac Arrest 349 620
Stenosis 337 338
Aortic Insufficiency 322 327
Pericardial Effusion 312 312
Bradycardia 305 305
Heart Block 304 828
Cardiac Perforation 292 507
No Clinical Signs, Symptoms or Conditions 289 289
Thrombosis 269 301
Failure of Implant 242 242
Perforation 242 467
Obstruction/Occlusion 234 254
Dyspnea 200 203
Endocarditis 195 210
Hematoma 185 358
Mitral Regurgitation 183 183
Transient Ischemic Attack 183 253
Thrombus 182 184
Regurgitation 178 178
Insufficient Information 177 2575
Congestive Heart Failure 170 170
Valvular Insufficiency/ Regurgitation 158 158
Perforation of Vessels 157 162
Intimal Dissection 156 156
Ventricular Fibrillation 140 140
Heart Failure 135 136
Regurgitation, Valvular 123 123
Pseudoaneurysm 122 122
Renal Failure 121 179
Aortic Valve Insufficiency/ Regurgitation 120 182
No Patient Involvement 89 89
Cardiogenic Shock 86 86
Unspecified Infection 86 126
Ischemia 85 468
Embolism 82 82
Low Cardiac Output 77 77
Chest Pain 69 69
Ventricular Tachycardia 64 64
Patient Problem/Medical Problem 63 64
Heart Failure/Congestive Heart Failure 60 60
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 59 486
Syncope 57 58
Thromboembolism 56 56
Fistula 55 55
Tissue Damage 54 55
Tachycardia 52 52
Foreign Body In Patient 51 52
Hemorrhage, Cerebral 50 50
Thrombosis/Thrombus 48 62
High Blood Pressure/ Hypertension 46 46
Tricuspid Regurgitation 44 44
Fatigue 41 42
Cardiopulmonary Arrest 39 39
Fever 35 35
Laceration(s) 35 35
Paralysis 35 35
Pleural Effusion 34 34
Sepsis 34 34
Exsanguination 34 34
Extravasation 33 33
Valvular Stenosis 33 33
Weakness 32 32
Embolus 32 32
Pain 31 32
Dizziness 31 31
Device Embedded In Tissue or Plaque 31 31
Pulmonary Edema 29 29
Pulmonary Regurgitation 29 29
Hemostasis 28 28
Multiple Organ Failure 27 27
Cardiovascular Insufficiency 27 439
Complaint, Ill-Defined 25 25
Cardiac Enzyme Elevation 24 24
Corneal Pannus 24 24

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jan-09-2021
2 CryoLife, Inc. II Sep-06-2017
3 Edwards Lifesciences, LLC I Aug-21-2019
4 Edwards Lifesciences, LLC II Feb-14-2019
5 Edwards Lifesciences, LLC II Jul-13-2018
6 Edwards Lifesciences, LLC I Jan-10-2018
7 Medtronic Cardiovascular Surgery-the Heart Valve Division II Aug-16-2016
8 Medtronic Heart Valves Division II Dec-10-2020
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