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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heart-valve, mechanical
Product CodeLWQ
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
8 4 6 9 8 5

MDR Year MDR Reports MDR Events
2018 434 434
2019 350 350
2020 372 372
2021 287 287
2022 297 297
2023 311 311

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 659 659
Insufficient Information 576 576
Incomplete Coaptation 129 129
Perivalvular Leak 119 119
Obstruction of Flow 112 112
Fracture 102 102
Biocompatibility 80 80
Physical Resistance/Sticking 73 73
Inadequacy of Device Shape and/or Size 68 68
Detachment of Device or Device Component 57 57
Gradient Increase 56 56
Difficult to Open or Close 54 54
Material Separation 52 52
Appropriate Term/Code Not Available 52 52
Device Dislodged or Dislocated 41 41
Patient Device Interaction Problem 33 33
Backflow 28 28
Mechanical Jam 27 27
Patient-Device Incompatibility 20 20
No Apparent Adverse Event 17 17
Break 15 15
Calcified 9 9
Improper or Incorrect Procedure or Method 9 9
Material Split, Cut or Torn 9 9
Microbial Contamination of Device 7 7
Material Too Rigid or Stiff 7 7
Off-Label Use 6 6
Mechanical Problem 6 6
Migration or Expulsion of Device 6 6
Degraded 6 6
Use of Device Problem 6 6
Structural Problem 6 6
Material Integrity Problem 6 6
Device Markings/Labelling Problem 5 5
Defective Device 5 5
Material Fragmentation 5 5
Leak/Splash 5 5
Device Stenosis 5 5
Central Regurgitation 4 4
Fluid/Blood Leak 4 4
Crack 4 4
Device Damaged by Another Device 4 4
Device Operates Differently Than Expected 3 3
Human-Device Interface Problem 3 3
Positioning Problem 3 3
Detachment Of Device Component 3 3
Partial Blockage 2 2
Material Frayed 2 2
Difficult or Delayed Positioning 2 2
Pacing Problem 2 2
Product Quality Problem 2 2
Scratched Material 2 2
Separation Problem 2 2
Missing Information 2 2
Lack of Effect 1 1
Mechanics Altered 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
Infusion or Flow Problem 1 1
Material Deformation 1 1
Measurement System Incompatibility 1 1
Escape 1 1
Gas/Air Leak 1 1
Malposition of Device 1 1
Contamination /Decontamination Problem 1 1
Activation, Positioning or Separation Problem 1 1
Separation Failure 1 1
Unraveled Material 1 1
Insufficient Flow or Under Infusion 1 1
Material Perforation 1 1
Defective Component 1 1
Material Puncture/Hole 1 1
Failure to Sense 1 1
Shipping Damage or Problem 1 1
Pitted 1 1
Delivered as Unsterile Product 1 1
Unintended System Motion 1 1
Material Erosion 1 1
Device Expiration Issue 1 1
Difficult to Insert 1 1
Burst Container or Vessel 1 1
Coagulation in Device or Device Ingredient 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Information 304 305
Insufficient Information 257 257
No Clinical Signs, Symptoms or Conditions 155 155
Endocarditis 143 143
Death 133 133
No Known Impact Or Consequence To Patient 123 123
Stroke/CVA 104 105
Hemorrhage/Bleeding 101 101
Thrombus 82 82
Thrombosis/Thrombus 81 81
Atrial Fibrillation 69 69
Aortic Valve Stenosis 68 68
Dyspnea 66 66
No Consequences Or Impact To Patient 62 62
No Code Available 60 60
Arrhythmia 59 59
Aortic Valve Insufficiency/ Regurgitation 54 54
Corneal Pannus 49 49
Unspecified Infection 43 43
Heart Failure/Congestive Heart Failure 42 42
Thromboembolism 41 41
Heart Block 39 39
Aortic Regurgitation 38 38
Mitral Regurgitation 35 35
Valvular Insufficiency/ Regurgitation 35 35
Cardiac Arrest 33 33
Mitral Valve Stenosis 31 31
Thrombosis 31 31
Mitral Valve Insufficiency/ Regurgitation 31 31
Pericardial Effusion 31 31
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 29 29
Aortic Insufficiency 29 29
Non specific EKG/ECG Changes 27 27
Renal Failure 27 27
Regurgitation 26 26
Myocardial Infarction 25 25
Pseudoaneurysm 23 23
Tachycardia 23 23
Heart Failure 21 21
Hematoma 21 21
Anemia 21 21
Congestive Heart Failure 21 21
Embolism 19 20
Low Cardiac Output 19 19
Cardiac Tamponade 19 19
Obstruction/Occlusion 18 18
Insufficiency, Valvular 18 18
Host-Tissue Reaction 17 17
Mitral Insufficiency 17 17
Pulmonary Edema 17 17
Pleural Effusion 16 16
Cardiogenic Shock 16 16
Chest Pain 16 16
High Blood Pressure/ Hypertension 15 15
Hemolytic Anemia 15 15
Complete Heart Block 15 15
Sepsis 15 15
Transient Ischemic Attack 15 15
Hemolysis 14 14
Blood Loss 14 14
Calcium Deposits/Calcification 13 13
Ventricular Fibrillation 13 13
Stenosis 13 13
Aneurysm 12 12
Low Blood Pressure/ Hypotension 12 12
Pneumonia 11 11
Regurgitation, Valvular 10 10
Hypoxia 9 9
Hemoptysis 9 9
Foreign Body Reaction 9 9
Valvular Stenosis 9 9
Abscess 8 8
Bradycardia 8 8
Occlusion 8 8
Paresis 7 7
Aortic Dissection 7 7
Atrial Flutter 7 7
Intracranial Hemorrhage 7 7
Fatigue 7 7
Respiratory Insufficiency 7 7
Syncope/Fainting 6 6
Ischemia Stroke 6 6
Failure of Implant 6 6
Angina 6 6
Respiratory Failure 6 6
Cardiac Perforation 5 5
Septic Shock 5 5
Rupture 5 5
Bacterial Infection 5 5
Infarction, Cerebral 5 5
Ischemia 4 5
Left Ventricular Dysfunction 4 4
Fever 4 4
Pneumothorax 4 4
Sudden Cardiac Death 4 4
Convulsion/Seizure 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Unspecified Heart Problem 4 4
Cardiovascular Insufficiency 4 4
Multiple Organ Failure 4 4

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Mar-28-2019
2 MEDTRONIC ATS MEDICAL, INC. II Mar-20-2020
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