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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)
2019 2020 2021 2022 2023 2024
50 32 18 37 26 14

MDR Year MDR Reports MDR Events
2019 1855 1855
2020 1437 1437
2021 1550 1550
2022 1084 1084
2023 1593 1593
2024 381 381

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 2986 2986
Adverse Event Without Identified Device or Use Problem 915 915
Material Split, Cut or Torn 709 709
Gradient Increase 693 693
Degraded 635 635
Perivalvular Leak 606 606
Calcified 553 553
Patient-Device Incompatibility 412 412
Backflow 378 378
Obstruction of Flow 367 367
Incomplete Coaptation 316 316
Fluid/Blood Leak 286 286
Patient Device Interaction Problem 286 286
Central Regurgitation 269 269
Inadequacy of Device Shape and/or Size 240 240
Device Stenosis 212 212
Biocompatibility 138 138
Difficult to Open or Close 116 116
Leak/Splash 114 114
Detachment of Device or Device Component 82 82
Material Deformation 81 81
Appropriate Term/Code Not Available 76 76
Collapse 61 61
Material Separation 52 52
Off-Label Use 49 49
Device Dislodged or Dislocated 48 48
Material Too Rigid or Stiff 37 37
Malposition of Device 34 34
Migration 28 28
Material Puncture/Hole 28 28
Material Perforation 23 23
Partial Blockage 23 23
Positioning Failure 23 23
Difficult to Fold, Unfold or Collapse 21 21
Therapeutic or Diagnostic Output Failure 19 19
Infusion or Flow Problem 18 18
Material Integrity Problem 18 18
Migration or Expulsion of Device 18 18
Microbial Contamination of Device 16 16
Use of Device Problem 16 16
Improper or Incorrect Procedure or Method 15 15
Structural Problem 14 14
Material Twisted/Bent 14 14
Improper Flow or Infusion 12 12
Reflux within Device 12 12
Material Rupture 12 12
Break 11 11
Difficult or Delayed Separation 11 11
No Apparent Adverse Event 10 10
Thickening of Material 9 9
Fracture 9 9
Stretched 8 8
Separation Problem 8 8
Activation Failure 8 8
Naturally Worn 8 8
Positioning Problem 7 7
Unintended Movement 7 7
Defective Device 7 7
Tear, Rip or Hole in Device Packaging 6 6
Mechanical Jam 6 6
Missing Information 6 6
Human-Device Interface Problem 5 5
Contamination /Decontamination Problem 5 5
Entrapment of Device 5 5
Nonstandard Device 4 4
Peeled/Delaminated 4 4
Expiration Date Error 4 4
Product Quality Problem 4 4
Scratched Material 4 4
Manufacturing, Packaging or Shipping Problem 4 4
Gas/Air Leak 3 3
Activation, Positioning or Separation Problem 3 3
Device Damaged by Another Device 3 3
Physical Resistance/Sticking 3 3
Device Appears to Trigger Rejection 3 3
Device Damaged Prior to Use 3 3
Mechanical Problem 3 3
Pitted 2 2
Material Invagination 2 2
Material Frayed 2 2
Complete Blockage 2 2
Difficult or Delayed Positioning 2 2
Burst Container or Vessel 2 2
Defective Component 2 2
Dent in Material 2 2
Unstable 2 2
Insufficient Flow or Under Infusion 2 2
Fitting Problem 2 2
Device Contaminated at the User Facility 2 2
Device-Device Incompatibility 2 2
Packaging Problem 2 2
Loosening of Implant Not Related to Bone-Ingrowth 2 2
Misassembly by Users 1 1
Device Contaminated During Manufacture or Shipping 1 1
Output Problem 1 1
Difficult to Advance 1 1
Free or Unrestricted Flow 1 1
Device Markings/Labelling Problem 1 1
Inadequate Instructions for Non-Healthcare Professional 1 1
Mechanics Altered 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 1809 1809
Aortic Valve Insufficiency/ Regurgitation 1171 1171
Aortic Valve Stenosis 1088 1088
No Information 770 770
Dyspnea 602 602
Endocarditis 582 582
Aortic Regurgitation 513 513
Aortic Insufficiency 482 482
Heart Failure/Congestive Heart Failure 480 480
No Clinical Signs, Symptoms or Conditions 317 317
No Known Impact Or Consequence To Patient 255 255
Complete Heart Block 250 250
Death 233 233
Calcium Deposits/Calcification 212 212
Hemorrhage/Bleeding 207 207
Stroke/CVA 184 184
Mitral Valve Insufficiency/ Regurgitation 181 181
Thrombosis/Thrombus 146 146
Heart Block 139 139
Atrial Fibrillation 126 126
Heart Failure 111 111
Pulmonary Valve Stenosis 102 102
Non specific EKG/ECG Changes 102 102
Mitral Valve Stenosis 100 100
Fatigue 99 99
Mitral Regurgitation 95 95
Arrhythmia 87 88
Corneal Pannus 80 80
Renal Failure 80 81
Valvular Insufficiency/ Regurgitation 79 79
Cusp Tear 78 78
Stenosis 78 78
Chest Pain 78 78
Myocardial Infarction 72 72
Unspecified Infection 71 71
Thrombus 67 68
Obstruction/Occlusion 61 61
Pseudoaneurysm 56 56
Cardiogenic Shock 50 50
No Consequences Or Impact To Patient 50 50
Cardiac Arrest 50 50
Thrombosis 46 46
Bradycardia 45 45
No Code Available 45 45
Low Blood Pressure/ Hypotension 43 43
Fever 42 42
Pulmonary Valve Insufficiency/ Regurgitation 42 42
Low Cardiac Output 41 41
Insufficiency, Valvular 41 41
Sepsis 40 40
Pulmonary Regurgitation 40 40
Aneurysm 40 40
Pulmonary Edema 39 39
Rupture 39 39
Regurgitation 39 39
Thrombocytopenia 39 39
Failure of Implant 37 37
Congestive Heart Failure 37 37
Abscess 36 36
Pleural Effusion 35 35
Thromboembolism 34 34
Blood Loss 33 33
Angina 33 33
Regurgitation, Valvular 32 32
Cardiac Tamponade 30 30
Hematoma 28 28
Foreign Body Reaction 28 28
High Blood Pressure/ Hypertension 26 26
Host-Tissue Reaction 26 26
Transient Ischemic Attack 26 26
Ventricular Fibrillation 25 25
Pulmonary Insufficiency 25 25
Pericardial Effusion 25 25
Tachycardia 23 23
Laceration(s) 20 20
Hemolysis 20 20
Vascular Dissection 20 20
Tricuspid Valve Insufficiency/ Regurgitation 20 20
Swelling/ Edema 20 20
Valvular Stenosis 19 19
Respiratory Failure 19 19
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 18 18
Dizziness 18 18
Bacterial Infection 17 17
Hemolytic Anemia 15 15
Syncope/Fainting 13 13
Anemia 13 13
Mitral Insufficiency 13 13
Perforation 13 13
Pneumonia 12 12
Ischemia 12 12
Tricuspid Regurgitation 12 12
Tricuspid Valve Stenosis 12 12
Syncope 12 12
Embolism 12 12
Vascular System (Circulation), Impaired 12 12
Multiple Organ Failure 11 11
Aortic Dissection 11 11
Embolism/Embolus 11 11
Pulmonary Hypertension 11 11

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