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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)
2018 2019 2020 2021 2022 2023
43 59 48 42 41 3

MDR Year MDR Reports MDR Events
2018 3916 5380
2019 4363 9092
2020 5809 16019
2021 5621 22468
2022 6001 27667

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 12009 35821
Perivalvular Leak 2756 2790
Insufficient Information 2735 33953
Device Dislodged or Dislocated 2576 2786
Malposition of Device 1074 1074
Burst Container or Vessel 857 857
Difficult to Remove 822 822
Gradient Increase 800 800
Fluid/Blood Leak 786 786
Material Split, Cut or Torn 679 679
Calcified 582 582
Material Separation 562 562
Degraded 537 537
Material Deformation 533 533
Material Rupture 469 469
Difficult or Delayed Positioning 455 455
Appropriate Term/Code Not Available 449 472
Difficult to Advance 403 403
Migration or Expulsion of Device 391 401
Activation Failure 388 388
Migration 353 380
Patient Device Interaction Problem 349 349
Physical Resistance/Sticking 337 337
Leak/Splash 269 269
Positioning Problem 262 488
Failure to Advance 259 259
Detachment of Device or Device Component 248 248
Material Twisted/Bent 240 240
Incomplete Coaptation 206 206
Inadequacy of Device Shape and/or Size 182 182
Difficult to Open or Close 178 178
Inflation Problem 172 172
Difficult to Insert 168 168
Peeled/Delaminated 149 149
Activation, Positioning or Separation Problem 139 139
Break 134 134
Deformation Due to Compressive Stress 105 105
Improper or Incorrect Procedure or Method 100 100
Unintended Movement 100 100
Patient-Device Incompatibility 92 94
Failure to Align 84 84
Obstruction of Flow 84 95
Structural Problem 82 82
Material Puncture/Hole 82 82
Fracture 82 82
No Apparent Adverse Event 80 80
Material Invagination 77 77
Entrapment of Device 76 76
Positioning Failure 73 79
Material Integrity Problem 67 67
Particulates 63 63
Torn Material 63 63
Activation Problem 59 59
Difficult or Delayed Activation 56 56
Mechanical Problem 52 55
Inaccurate Delivery 52 52
Deflation Problem 49 49
Material Fragmentation 44 44
Retraction Problem 41 41
Use of Device Problem 41 41
Therapeutic or Diagnostic Output Failure 38 38
Material Protrusion/Extrusion 36 36
Device Damaged by Another Device 32 32
Difficult To Position 28 28
Failure to Conduct 28 172
Backflow 26 26
Defective Device 25 25
Device Slipped 23 23
Contamination /Decontamination Problem 23 23
Separation Problem 22 22
Mechanical Jam 20 20
Difficult to Fold, Unfold or Collapse 20 20
Device-Device Incompatibility 17 17
Pacing Problem 17 143
Thickening of Material 16 16
Device Difficult to Setup or Prepare 16 16
Crack 14 14
Coagulation in Device or Device Ingredient 12 32
Complete Blockage 12 12
Central Regurgitation 11 11
Failure to Capture 11 11
Loss of or Failure to Bond 11 11
Incorrect, Inadequate or Imprecise Result or Readings 9 9
Unintended Collision 9 9
Reflux within Device 9 9
Device Operates Differently Than Expected 9 9
Separation Failure 8 8
Partial Blockage 8 8
Device Contamination with Chemical or Other Material 8 8
Material Perforation 8 8
Noise, Audible 8 8
Output Problem 8 8
Component Missing 7 7
Detachment Of Device Component 7 7
Contamination 7 7
Off-Label Use 7 7
Human-Device Interface Problem 6 6
Physical Resistance 6 6
Material Too Rigid or Stiff 6 6
Microbial Contamination of Device 6 6

Patient Problems MDRs with this Patient Problem Events in those MDRs
Non specific EKG/ECG Changes 2565 3830
Complete Heart Block 2272 2274
No Clinical Signs, Symptoms or Conditions 2087 2087
Heart Block 1965 11953
No Known Impact Or Consequence To Patient 1931 1945
Stroke/CVA 1927 4747
Insufficient Information 1714 7314
Injury 1473 4801
Arrhythmia 1311 7749
Death 1288 2741
Aortic Regurgitation 1170 1199
Vascular Dissection 1138 2104
No Consequences Or Impact To Patient 1134 1134
Hemorrhage/Bleeding 1083 3134
Rupture 1034 1147
Low Blood Pressure/ Hypotension 982 984
Valvular Insufficiency/ Regurgitation 851 873
Blood Loss 718 873
Aortic Valve Stenosis 681 691
Obstruction/Occlusion 646 1172
Myocardial Infarction 643 1399
Calcium Deposits/Calcification 634 636
No Code Available 622 726
Aortic Valve Insufficiency/ Regurgitation 574 1192
Cardiac Arrest 521 2034
Dyspnea 446 449
Vascular System (Circulation), Impaired 444 1526
Atrial Fibrillation 442 442
Heart Failure/Congestive Heart Failure 438 610
Infarction, Cerebral 428 808
Insufficiency, Valvular 425 425
Cardiac Tamponade 407 495
Occlusion 386 392
Pericardial Effusion 382 382
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 342 4952
Stenosis 328 329
Bradycardia 326 326
Cardiac Perforation 322 1125
Endocarditis 315 449
Aortic Dissection 287 334
No Information 279 6251
Thrombosis/Thrombus 277 475
Perforation 259 675
Transient Ischemic Attack 235 590
Perforation of Vessels 224 289
Aortic Insufficiency 222 227
Thrombosis 203 235
Failure of Implant 201 201
Hematoma 200 466
Foreign Body In Patient 186 187
Regurgitation 172 172
Ventricular Fibrillation 172 172
Cardiovascular Insufficiency 158 2826
Renal Failure 154 431
Thrombus 144 146
Unspecified Vascular Problem 133 1275
Intimal Dissection 132 132
Mitral Regurgitation 130 130
Unspecified Infection 127 395
Pseudoaneurysm 125 125
Chest Pain 118 118
Cardiogenic Shock 117 117
Regurgitation, Valvular 112 112
Congestive Heart Failure 112 112
Heart Failure 111 112
Ischemia Stroke 108 1815
Low Cardiac Output 106 106
Tachycardia 99 99
Ischemia 97 480
No Patient Involvement 86 86
Embolism 77 77
Thromboembolism 74 74
Paralysis 69 69
Mitral Valve Insufficiency/ Regurgitation 69 69
Fatigue 64 65
Patient Problem/Medical Problem 63 64
High Blood Pressure/ Hypertension 59 59
Foreign Body Embolism 56 56
Dizziness 52 52
Tissue Damage 52 53
Anemia 51 52
Pain 50 51
Pulmonary Edema 50 50
Ventricular Tachycardia 50 50
Hemolysis 48 48
Fever 47 47
Sepsis 46 46
Pleural Effusion 46 46
Fistula 46 46
Great Vessel Perforation 44 44
Cusp Tear 44 44
Syncope 43 44
Muscle Weakness 42 42
Valvular Stenosis 41 41
Pulmonary Dysfunction 41 408
Unspecified Tissue Injury 41 41
Embolism/Embolus 40 40
Tricuspid Regurgitation 39 39
Cardiac Enzyme Elevation 38 38
Syncope/Fainting 37 37

Recalls
Manufacturer Recall Class Date Posted
1 Boston Scientific Corporation I Jan-09-2021
2 Edwards Lifesciences, LLC I Aug-21-2019
3 Edwards Lifesciences, LLC II Feb-14-2019
4 Edwards Lifesciences, LLC II Jul-13-2018
5 Edwards Lifesciences, LLC I Jan-10-2018
6 Medtronic Heart Valves Division II Jul-09-2021
7 Medtronic Heart Valves Division II Dec-10-2020
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