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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)
2019 2020 2021 2022 2023 2024
4 6 9 8 9 5

MDR Year MDR Reports MDR Events
2019 350 350
2020 372 372
2021 287 287
2022 297 297
2023 455 455
2024 197 197

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 588 588
Insufficient Information 494 494
Incomplete Coaptation 150 150
Physical Resistance/Sticking 121 121
Perivalvular Leak 114 114
Fracture 102 102
Obstruction of Flow 78 78
Biocompatibility 78 78
Patient Device Interaction Problem 77 77
Detachment of Device or Device Component 68 68
Inadequacy of Device Shape and/or Size 61 61
Difficult to Open or Close 55 55
Material Separation 52 52
Patient-Device Incompatibility 37 37
Gradient Increase 36 36
Appropriate Term/Code Not Available 31 31
Backflow 28 28
Device Dislodged or Dislocated 22 22
Device Stenosis 19 19
Central Regurgitation 17 17
Mechanical Jam 16 16
Improper or Incorrect Procedure or Method 13 13
Off-Label Use 12 12
Break 12 12
No Apparent Adverse Event 12 12
Material Split, Cut or Torn 9 9
Device Markings/Labelling Problem 8 8
Calcified 8 8
Degraded 8 8
Migration or Expulsion of Device 6 6
Use of Device Problem 6 6
Material Integrity Problem 6 6
Device Damaged by Another Device 4 4
Crack 4 4
Leak/Splash 3 3
Mechanical Problem 3 3
Unsealed Device Packaging 3 3
Microbial Contamination of Device 3 3
Packaging Problem 3 3
Positioning Problem 2 2
Scratched Material 2 2
Defective Device 2 2
Structural Problem 2 2
Contamination /Decontamination Problem 2 2
Human-Device Interface Problem 2 2
Pacing Problem 2 2
Product Quality Problem 2 2
Material Too Rigid or Stiff 2 2
Material Frayed 2 2
Difficult or Delayed Positioning 2 2
Fluid/Blood Leak 1 1
Coagulation in Device or Device Ingredient 1 1
Burst Container or Vessel 1 1
Partial Blockage 1 1
Material Fragmentation 1 1
Difficult to Insert 1 1
Failure to Sense 1 1
Material Puncture/Hole 1 1
Pitted 1 1
Insufficient Flow or Under Infusion 1 1
Material Perforation 1 1
Shipping Damage or Problem 1 1
Unraveled Material 1 1
Material Deformation 1 1
Gas/Air Leak 1 1
Expiration Date Error 1 1
Malposition of Device 1 1
Therapeutic or Diagnostic Output Failure 1 1
Mechanics Altered 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Separation Problem 1 1
Thickening of Material 1 1
Lack of Effect 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 336 336
No Clinical Signs, Symptoms or Conditions 250 250
No Information 201 201
Endocarditis 126 126
Stroke/CVA 116 116
Hemorrhage/Bleeding 109 109
Thrombosis/Thrombus 102 102
No Known Impact Or Consequence To Patient 84 84
Death 80 80
Dyspnea 76 76
Atrial Fibrillation 71 71
Aortic Valve Insufficiency/ Regurgitation 71 71
Heart Failure/Congestive Heart Failure 70 70
Aortic Valve Stenosis 58 58
Thrombus 55 55
Heart Block 50 50
No Consequences Or Impact To Patient 41 41
Unspecified Infection 41 41
Mitral Valve Insufficiency/ Regurgitation 38 38
Valvular Insufficiency/ Regurgitation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 38 38
Corneal Pannus 34 34
Non specific EKG/ECG Changes 32 32
Arrhythmia 31 31
Thromboembolism 31 31
Pericardial Effusion 29 29
Cardiac Arrest 29 29
Myocardial Infarction 28 28
No Code Available 28 28
Renal Failure 27 27
Anemia 27 27
Obstruction/Occlusion 26 26
Aortic Regurgitation 25 25
Mitral Valve Stenosis 23 23
Pseudoaneurysm 23 23
Thrombosis 23 23
Tachycardia 22 22
Mitral Regurgitation 21 21
Pulmonary Edema 19 19
Transient Ischemic Attack 19 19
Cardiac Tamponade 19 19
Low Cardiac Output 18 18
Pleural Effusion 18 18
Hematoma 18 18
Hemolytic Anemia 17 17
Ventricular Fibrillation 16 16
Sepsis 15 15
Cardiogenic Shock 15 15
Heart Failure 15 15
Hemolysis 15 15
Aortic Insufficiency 15 15
Chest Pain 15 15
Embolism 14 14
Insufficiency, Valvular 14 14
High Blood Pressure/ Hypertension 14 14
Low Blood Pressure/ Hypotension 14 14
Pneumonia 12 12
Respiratory Insufficiency 12 12
Hypoxia 11 11
Failure of Implant 10 10
Fatigue 10 10
Foreign Body Reaction 10 10
Bradycardia 10 10
Aneurysm 10 10
Stenosis 10 10
Regurgitation 9 9
Host-Tissue Reaction 9 9
Intracranial Hemorrhage 9 9
Mitral Insufficiency 9 9
Complete Heart Block 9 9
Blood Loss 8 8
Ischemia Stroke 8 8
Embolism/Embolus 8 8
Hemoptysis 8 8
Angina 8 8
Atrial Flutter 7 7
Abscess 7 7
Paresis 7 7
Occlusion 7 7
Syncope/Fainting 7 7
Tricuspid Valve Insufficiency/ Regurgitation 7 7
Valvular Stenosis 6 6
Calcium Deposits/Calcification 6 6
Infarction, Cerebral 5 5
Ischemia 5 5
Septic Shock 5 5
Respiratory Failure 5 5
Unspecified Heart Problem 5 5
Pulmonary Hypertension 4 4
Cardiovascular Insufficiency 4 4
Foreign Body In Patient 4 4
Convulsion/Seizure 4 4
Post Operative Wound Infection 4 4
Cardiac Perforation 4 4
Regurgitation, Valvular 4 4
Pneumothorax 4 4
Fever 4 4
Congestive Heart Failure 4 4
Cardiomyopathy 3 3
Bacterial Infection 3 3

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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