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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 3

MDR Year MDR Reports MDR Events
2019 350 350
2020 372 372
2021 287 287
2022 297 297
2023 455 455
2024 91 91

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 559 559
Insufficient Information 485 485
Incomplete Coaptation 137 137
Perivalvular Leak 109 109
Physical Resistance/Sticking 105 105
Fracture 99 99
Obstruction of Flow 78 78
Biocompatibility 78 78
Detachment of Device or Device Component 64 64
Patient Device Interaction Problem 58 58
Inadequacy of Device Shape and/or Size 56 56
Difficult to Open or Close 54 54
Material Separation 52 52
Gradient Increase 35 35
Patient-Device Incompatibility 32 32
Appropriate Term/Code Not Available 31 31
Backflow 28 28
Device Dislodged or Dislocated 22 22
Mechanical Jam 16 16
Device Stenosis 14 14
No Apparent Adverse Event 12 12
Break 12 12
Improper or Incorrect Procedure or Method 11 11
Off-Label Use 9 9
Central Regurgitation 9 9
Device Markings/Labelling Problem 8 8
Calcified 8 8
Material Split, Cut or Torn 7 7
Material Integrity Problem 6 6
Degraded 6 6
Migration or Expulsion of Device 6 6
Use of Device Problem 6 6
Crack 4 4
Device Damaged by Another Device 4 4
Leak/Splash 3 3
Mechanical Problem 3 3
Microbial Contamination of Device 3 3
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
Contamination /Decontamination Problem 2 2
Structural Problem 2 2
Defective Device 2 2
Human-Device Interface Problem 2 2
Positioning Problem 2 2
Scratched Material 2 2
Therapeutic or Diagnostic Output Failure 1 1
Device Handling Problem 1 1
Noise, Audible 1 1
Separation Problem 1 1
Lack of Effect 1 1
Material Deformation 1 1
Gas/Air Leak 1 1
Mechanics Altered 1 1
Malposition of Device 1 1
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

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 313 313
No Clinical Signs, Symptoms or Conditions 223 223
No Information 201 201
Endocarditis 121 121
Stroke/CVA 109 109
Hemorrhage/Bleeding 103 103
Thrombosis/Thrombus 95 95
No Known Impact Or Consequence To Patient 84 84
Death 80 80
Dyspnea 69 69
Atrial Fibrillation 69 69
Aortic Valve Insufficiency/ Regurgitation 67 67
Heart Failure/Congestive Heart Failure 60 60
Aortic Valve Stenosis 56 56
Thrombus 55 55
Heart Block 47 47
No Consequences Or Impact To Patient 41 41
Unspecified Infection 41 41
Valvular Insufficiency/ Regurgitation 38 38
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 37 37
Mitral Valve Insufficiency/ Regurgitation 35 35
Corneal Pannus 34 34
Thromboembolism 31 31
Arrhythmia 30 30
Cardiac Arrest 29 29
Pericardial Effusion 29 29
No Code Available 28 28
Myocardial Infarction 26 26
Renal Failure 26 26
Aortic Regurgitation 25 25
Non specific EKG/ECG Changes 24 24
Thrombosis 23 23
Mitral Valve Stenosis 22 22
Pseudoaneurysm 22 22
Obstruction/Occlusion 21 21
Tachycardia 21 21
Mitral Regurgitation 21 21
Anemia 19 19
Pulmonary Edema 19 19
Pleural Effusion 18 18
Cardiac Tamponade 18 18
Low Cardiac Output 18 18
Hematoma 18 18
Hemolytic Anemia 17 17
Transient Ischemic Attack 16 16
Ventricular Fibrillation 15 15
Sepsis 15 15
Cardiogenic Shock 15 15
Heart Failure 15 15
Aortic Insufficiency 15 15
Embolism 14 14
Chest Pain 14 14
Hemolysis 14 14
Low Blood Pressure/ Hypotension 14 14
Insufficiency, Valvular 14 14
High Blood Pressure/ Hypertension 13 13
Pneumonia 12 12
Respiratory Insufficiency 12 12
Hypoxia 11 11
Aneurysm 10 10
Stenosis 10 10
Regurgitation 9 9
Complete Heart Block 9 9
Host-Tissue Reaction 9 9
Bradycardia 9 9
Failure of Implant 9 9
Mitral Insufficiency 9 9
Intracranial Hemorrhage 9 9
Foreign Body Reaction 9 9
Hemoptysis 8 8
Ischemia Stroke 8 8
Blood Loss 8 8
Fatigue 7 7
Angina 7 7
Atrial Flutter 7 7
Abscess 7 7
Occlusion 7 7
Paresis 7 7
Calcium Deposits/Calcification 6 6
Syncope/Fainting 6 6
Valvular Stenosis 6 6
Infarction, Cerebral 5 5
Septic Shock 5 5
Respiratory Failure 5 5
Regurgitation, Valvular 4 4
Cardiac Perforation 4 4
Pneumothorax 4 4
Congestive Heart Failure 4 4
Fever 4 4
Convulsion/Seizure 4 4
Embolism/Embolus 4 4
Cardiovascular Insufficiency 4 4
Tricuspid Valve Insufficiency/ Regurgitation 4 4
Unspecified Heart Problem 4 4
Foreign Body Embolism 3 3
Hemorrhagic Stroke 3 3
Multiple Organ Failure 3 3
Foreign Body In Patient 3 3
Pulmonary Hypertension 3 3
Unspecified Kidney or Urinary Problem 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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