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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heart-valve, non-allograft tissue
Product CodeLWR
Device Class 3

Premarket Approvals (PMA)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
15 17 25 18 31 27 14 27 54 64 50 32 18 37 26 14

MDR Year MDR Reports MDR Events
2014 365 365
2015 525 525
2016 736 736
2017 1367 1367
2018 1593 1593
2019 1855 1855
2020 1437 1437
2021 1550 1550
2022 1084 1084
2023 1593 1593
2024 549 549

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 4663 4663
Adverse Event Without Identified Device or Use Problem 1583 1583
Gradient Increase 1210 1210
Perivalvular Leak 970 970
Material Split, Cut or Torn 782 782
Calcified 769 769
Degraded 672 672
Obstruction of Flow 523 523
Incomplete Coaptation 499 499
Patient-Device Incompatibility 479 479
Inadequacy of Device Shape and/or Size 382 382
Backflow 378 378
Leak/Splash 339 339
Central Regurgitation 316 316
Patient Device Interaction Problem 311 311
Fluid/Blood Leak 296 296
Torn Material 280 280
Device Stenosis 251 251
Appropriate Term/Code Not Available 238 238
Material Deformation 194 194
Biocompatibility 151 151
Device Operates Differently Than Expected 138 138
Difficult to Open or Close 119 119
Material Too Rigid or Stiff 108 108
Detachment of Device or Device Component 89 89
Material Separation 82 82
Occlusion Within Device 82 82
Structural Problem 81 81
Device Dislodged or Dislocated 74 74
Microbial Contamination of Device 67 67
Malposition of Device 66 66
Collapse 63 63
Off-Label Use 56 56
Material Rupture 54 54
Material Perforation 49 49
Material Puncture/Hole 38 38
Difficult to Fold, Unfold or Collapse 37 37
No Apparent Adverse Event 33 33
Break 31 31
Material Integrity Problem 30 30
Migration 30 30
Material Distortion 28 28
Therapeutic or Diagnostic Output Failure 26 26
Partial Blockage 26 26
Migration or Expulsion of Device 25 25
Use of Device Problem 24 24
Hole In Material 24 24
Positioning Failure 24 24
Improper or Incorrect Procedure or Method 21 21
Infusion or Flow Problem 19 19
Missing Information 19 19
Material Twisted/Bent 17 17
Improper Flow or Infusion 15 15
Reflux within Device 15 15
Naturally Worn 14 14
Activation Failure 14 14
Positioning Problem 13 13
Folded 13 13
Kinked 13 13
Material Disintegration 13 13
Fracture 12 12
Thickening of Material 11 11
Difficult or Delayed Separation 11 11
Detachment Of Device Component 10 10
Stretched 9 9
Defective Device 9 9
Separation Problem 9 9
Unintended Movement 8 8
Mechanical Jam 6 6
Human-Device Interface Problem 6 6
Activation, Positioning or Separation Problem 6 6
Tear, Rip or Hole in Device Packaging 6 6
Contamination /Decontamination Problem 6 6
Loose or Intermittent Connection 6 6
Mechanical Problem 6 6
Entrapment of Device 6 6
Material Invagination 5 5
Crack 5 5
Product Quality Problem 5 5
Peeled/Delaminated 4 4
Nonstandard Device 4 4
Device Inoperable 4 4
Device Appears to Trigger Rejection 4 4
Complete Blockage 4 4
Material Discolored 4 4
Device Damaged by Another Device 4 4
Cut In Material 4 4
Defective Component 4 4
Expiration Date Error 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Scratched Material 4 4
Device Handling Problem 4 4
Physical Resistance/Sticking 3 3
Mechanics Altered 3 3
Gas/Air Leak 3 3
Device Contamination with Chemical or Other Material 3 3
Unstable 3 3
Material Erosion 3 3
Material Fragmentation 3 3
Material Frayed 3 3

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1875 1875
Aortic Valve Stenosis 1789 1789
No Information 1692 1695
Aortic Valve Insufficiency/ Regurgitation 1212 1212
Aortic Regurgitation 1193 1193
Aortic Insufficiency 1087 1087
Endocarditis 925 925
Dyspnea 806 806
Death 610 610
Calcium Deposits/Calcification 526 526
No Known Impact Or Consequence To Patient 511 511
Heart Failure/Congestive Heart Failure 496 496
Complete Heart Block 369 369
No Clinical Signs, Symptoms or Conditions 339 339
Mitral Regurgitation 312 312
Hemorrhage/Bleeding 273 273
Stroke/CVA 271 271
Corneal Pannus 260 260
Stenosis 236 236
Cusp Tear 219 219
No Code Available 208 208
Pulmonary Valve Stenosis 200 201
Atrial Fibrillation 194 194
Mitral Valve Stenosis 188 189
Mitral Valve Insufficiency/ Regurgitation 188 188
Heart Failure 181 181
Arrhythmia 173 174
Thrombus 168 169
Non specific EKG/ECG Changes 156 156
Thrombosis/Thrombus 149 149
Heart Block 145 145
Fatigue 135 135
Unspecified Infection 130 130
Renal Failure 116 117
Congestive Heart Failure 112 112
Myocardial Infarction 110 110
Chest Pain 106 106
Regurgitation 104 104
Pseudoaneurysm 98 98
Pulmonary Regurgitation 98 98
Thrombosis 90 90
Blood Loss 88 89
Insufficiency, Valvular 84 84
Cardiac Arrest 81 81
Valvular Insufficiency/ Regurgitation 80 80
Mitral Insufficiency 78 79
Obstruction/Occlusion 77 77
No Consequences Or Impact To Patient 73 73
Regurgitation, Valvular 71 71
Pulmonary Edema 71 71
Cardiogenic Shock 68 68
Low Blood Pressure/ Hypotension 66 66
Bradycardia 66 66
Pleural Effusion 64 64
Sepsis 64 64
Thromboembolism 64 64
Rupture 63 63
Aneurysm 59 59
Fever 59 59
Tricuspid Regurgitation 57 57
Abscess 56 56
Cardiac Tamponade 55 55
Hematoma 54 54
High Blood Pressure/ Hypertension 51 51
Low Cardiac Output 50 50
Failure of Implant 47 48
Host-Tissue Reaction 45 45
Transient Ischemic Attack 43 43
Pulmonary Valve Insufficiency/ Regurgitation 43 43
Angina 40 40
Thrombocytopenia 39 39
Pulmonary Insufficiency 37 38
Hemolysis 35 35
Valvular Stenosis 35 35
Respiratory Failure 34 34
Prolapse 34 34
Ventricular Fibrillation 34 34
Pericardial Effusion 33 33
Tachycardia 32 33
Bacterial Infection 31 31
Ischemia 30 30
Tricuspid Valve Stenosis 29 29
Foreign Body Reaction 28 28
Edema 27 27
Pneumonia 27 27
Perforation 26 26
Vascular Dissection 26 26
Dizziness 26 26
Laceration(s) 25 25
Injury 24 24
Multiple Organ Failure 24 24
Vascular System (Circulation), Impaired 23 23
Infarction, Cerebral 23 23
Anemia 23 23
Embolism 22 22
Hemolytic Anemia 22 22
Aortic Dissection 22 22
Cardiac Perforation 21 21
Tricuspid Valve Insufficiency/ Regurgitation 21 21
Occlusion 21 21

Recalls
Manufacturer Recall Class Date Posted
1 Medtronic Cardiovascular Surgery-the Heart Valve Division II Feb-03-2014
2 Sorin Group Italia S.r.l. II Sep-18-2020
3 Sorin Group USA, Inc. II Dec-07-2016
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