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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)
2020 2021 2022 2023 2024 2025
32 18 37 26 27 13

MDR Year MDR Reports MDR Events
2020 1437 1437
2021 1550 1550
2022 1084 1084
2023 1593 1593
2024 1831 1837
2025 901 901

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 3049 3049
Adverse Event Without Identified Device or Use Problem 920 923
Central Regurgitation 725 728
Degraded 686 686
Device Stenosis 652 655
Gradient Increase 616 616
Calcified 611 611
Material Split, Cut or Torn 591 591
Patient Device Interaction Problem 582 582
Perivalvular Leak 571 571
Backflow 361 361
Incomplete Coaptation 343 343
Patient-Device Incompatibility 327 327
Fluid/Blood Leak 309 309
Obstruction of Flow 275 275
Inadequacy of Device Shape and/or Size 239 239
Biocompatibility 122 122
Difficult to Open or Close 120 120
Detachment of Device or Device Component 85 85
Leak/Splash 66 66
Material Deformation 62 62
Appropriate Term/Code Not Available 48 48
Device Dislodged or Dislocated 44 44
Off-Label Use 40 40
Collapse 40 40
Material Separation 38 38
Break 35 35
Thickening of Material 34 34
Malposition of Device 27 27
Partial Blockage 23 23
Positioning Failure 22 22
Material Puncture/Hole 21 21
Material Too Rigid or Stiff 20 20
Migration 19 19
Therapeutic or Diagnostic Output Failure 18 18
Microbial Contamination of Device 18 18
Mechanical Jam 16 16
Use of Device Problem 14 14
Migration or Expulsion of Device 14 14
Material Twisted/Bent 13 13
Material Perforation 12 12
Material Integrity Problem 12 12
Improper or Incorrect Procedure or Method 12 12
Reflux within Device 11 11
Improper Flow or Infusion 11 11
Infusion or Flow Problem 11 11
Unsealed Device Packaging 10 10
Difficult or Delayed Separation 9 9
Difficult to Fold, Unfold or Collapse 9 9
Entrapment of Device 9 9

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2880 2880
Aortic Valve Insufficiency/ Regurgitation 1571 1574
Aortic Valve Stenosis 1061 1064
Dyspnea 771 771
Heart Failure/Congestive Heart Failure 739 739
Endocarditis 589 589
No Clinical Signs, Symptoms or Conditions 514 517
No Information 308 308
Aortic Regurgitation 253 253
Mitral Valve Insufficiency/ Regurgitation 248 248
Stroke/CVA 224 224
Thrombosis/Thrombus 215 215
Hemorrhage/Bleeding 212 212
Heart Block 201 201
Aortic Insufficiency 185 185
Calcium Deposits/Calcification 182 182
Atrial Fibrillation 166 166
Fatigue 149 149
Non specific EKG/ECG Changes 118 118
Mitral Valve Stenosis 108 108
Renal Failure 104 104
Chest Pain 96 96
Valvular Insufficiency/ Regurgitation 92 92
Death 87 87
Cusp Tear 85 85
Myocardial Infarction 83 83
No Known Impact Or Consequence To Patient 79 79
Arrhythmia 76 76
Obstruction/Occlusion 75 75
Unspecified Infection 73 73
Pulmonary Valve Stenosis 68 68
Heart Failure 65 65
Pseudoaneurysm 61 61
Cardiac Arrest 59 59
Complete Heart Block 56 56
Cardiogenic Shock 52 52
Fever 48 48
Rupture 47 47
Pulmonary Edema 47 47
Pulmonary Valve Insufficiency/ Regurgitation 46 46
Tachycardia 45 45
Bradycardia 45 45
Aneurysm 44 44
Thrombocytopenia 44 44
Stenosis 42 42
Mitral Regurgitation 42 42
Angina 40 40
Tricuspid Valve Insufficiency/ Regurgitation 39 39
Low Blood Pressure/ Hypotension 39 39
Failure of Implant 38 38

Recalls
Manufacturer Recall Class Date Posted
1 Sorin Group Italia S.r.l. II Sep-18-2020
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