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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 2

MDR Year MDR Reports MDR Events
2020 1437 1437
2021 1550 1550
2022 1084 1084
2023 1593 1593
2024 1815 1821
2025 139 139

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2769 2769
Adverse Event Without Identified Device or Use Problem 825 828
Degraded 647 647
Gradient Increase 597 597
Central Regurgitation 573 576
Material Split, Cut or Torn 572 572
Calcified 548 548
Perivalvular Leak 541 541
Device Stenosis 499 502
Patient Device Interaction Problem 483 483
Backflow 361 361
Incomplete Coaptation 314 314
Patient-Device Incompatibility 302 302
Fluid/Blood Leak 301 301
Obstruction of Flow 274 274
Inadequacy of Device Shape and/or Size 222 222
Biocompatibility 122 122
Difficult to Open or Close 119 119
Detachment of Device or Device Component 83 83
Leak/Splash 61 61
Material Deformation 58 58
Appropriate Term/Code Not Available 42 42
Device Dislodged or Dislocated 39 39
Collapse 38 38
Off-Label Use 37 37
Material Separation 35 35
Break 33 33
Malposition of Device 26 26
Partial Blockage 23 23
Thickening of Material 23 23
Positioning Failure 22 22
Material Puncture/Hole 20 20
Material Too Rigid or Stiff 20 20
Migration 19 19
Therapeutic or Diagnostic Output Failure 18 18
Microbial Contamination of Device 15 15
Migration or Expulsion of Device 14 14
Material Twisted/Bent 13 13
Use of Device Problem 12 12
Material Integrity Problem 12 12
Material Perforation 12 12
Mechanical Jam 12 12
Improper or Incorrect Procedure or Method 12 12
Improper Flow or Infusion 11 11
Infusion or Flow Problem 11 11
Reflux within Device 11 11
Entrapment of Device 9 9
Difficult to Fold, Unfold or Collapse 9 9
Difficult or Delayed Separation 9 9
Unsealed Device Packaging 8 8

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 2515 2515
Aortic Valve Insufficiency/ Regurgitation 1448 1451
Aortic Valve Stenosis 985 988
Dyspnea 674 674
Heart Failure/Congestive Heart Failure 637 637
Endocarditis 536 536
No Clinical Signs, Symptoms or Conditions 446 449
No Information 308 308
Aortic Regurgitation 253 253
Mitral Valve Insufficiency/ Regurgitation 229 229
Hemorrhage/Bleeding 199 199
Stroke/CVA 197 197
Thrombosis/Thrombus 196 196
Aortic Insufficiency 185 185
Heart Block 178 178
Calcium Deposits/Calcification 164 164
Atrial Fibrillation 143 143
Fatigue 130 130
Mitral Valve Stenosis 104 104
Non specific EKG/ECG Changes 103 103
Renal Failure 93 93
Chest Pain 88 88
Valvular Insufficiency/ Regurgitation 88 88
Death 87 87
Cusp Tear 80 80
No Known Impact Or Consequence To Patient 79 79
Myocardial Infarction 76 76
Arrhythmia 71 71
Unspecified Infection 68 68
Obstruction/Occlusion 68 68
Pulmonary Valve Stenosis 68 68
Heart Failure 65 65
Complete Heart Block 56 56
Pseudoaneurysm 56 56
Cardiac Arrest 54 54
Cardiogenic Shock 48 48
Pulmonary Edema 46 46
Fever 46 46
Pulmonary Valve Insufficiency/ Regurgitation 46 46
Mitral Regurgitation 42 42
Rupture 42 42
Thrombocytopenia 42 42
Aneurysm 40 40
Bradycardia 40 40
Stenosis 39 39
Failure of Implant 38 38
Angina 38 38
Low Blood Pressure/ Hypotension 37 37
Sepsis 36 36
Pleural Effusion 34 34

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