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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device pulmonic valved conduit
Product CodeMWH
Device Class Humanitarian Device Exemption

MDR Year MDR Reports MDR Events
2014 49 49
2015 74 74
2016 105 105
2017 96 96
2018 111 111
2019 128 128
2020 83 83
2021 79 79
2022 67 67
2023 57 57
2024 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 491 491
Gradient Increase 148 148
Adverse Event Without Identified Device or Use Problem 95 95
Calcified 75 75
Obstruction of Flow 42 42
Occlusion Within Device 39 39
Inadequacy of Device Shape and/or Size 26 26
Appropriate Term/Code Not Available 24 24
Degraded 16 16
Device Operates Differently Than Expected 15 15
Material Deformation 14 14
Patient Device Interaction Problem 14 14
Structural Problem 11 11
Incomplete Coaptation 11 11
Stretched 7 7
Partial Blockage 6 6
Material Split, Cut or Torn 4 4
Device Markings/Labelling Problem 4 4
No Apparent Adverse Event 4 4
Central Regurgitation 4 4
Material Distortion 3 3
Material Integrity Problem 3 3
Reflux within Device 3 3
Material Separation 3 3
Patient-Device Incompatibility 3 3
Biocompatibility 3 3
Restricted Flow rate 2 2
Fracture 2 2
Improper or Incorrect Procedure or Method 2 2
Peeled/Delaminated 2 2
Perivalvular Leak 2 2
Leak/Splash 2 2
Material Twisted/Bent 2 2
Human-Device Interface Problem 2 2
Thickening of Material 2 2
Device Stenosis 2 2
Device-Device Incompatibility 1 1
Device Dislodged or Dislocated 1 1
Separation Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Torn Material 1 1
Unintended Movement 1 1
Incorrect Measurement 1 1
Nonstandard Device 1 1
Increase in Pressure 1 1
Break 1 1
Complete Blockage 1 1
Material Discolored 1 1
Material Disintegration 1 1
Material Erosion 1 1
Material Perforation 1 1
Deformation Due to Compressive Stress 1 1
Delamination 1 1
Detachment of Device or Device Component 1 1
Expiration Date Error 1 1
Defective Device 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pulmonary Valve Stenosis 308 308
No Information 277 277
Insufficient Information 127 127
Pulmonary Regurgitation 113 113
Endocarditis 86 86
Pulmonary Valve Insufficiency/ Regurgitation 62 62
Stenosis 60 60
Calcium Deposits/Calcification 50 50
Pulmonary Insufficiency 39 39
Death 35 35
Obstruction/Occlusion 30 30
Regurgitation, Valvular 28 28
Thrombus 26 26
No Known Impact Or Consequence To Patient 26 26
Non specific EKG/ECG Changes 20 20
Aneurysm 20 20
Unspecified Infection 20 20
Insufficiency, Valvular 16 16
Pseudoaneurysm 15 15
Low Cardiac Output 14 14
Hemorrhage/Bleeding 14 14
High Blood Pressure/ Hypertension 13 13
Dyspnea 13 13
Stroke/CVA 12 12
Sepsis 12 12
Complete Heart Block 12 12
No Code Available 11 11
Vascular System (Circulation), Impaired 10 10
Blood Loss 10 10
Thrombosis 9 9
Thrombosis/Thrombus 9 9
Congestive Heart Failure 9 9
Arrhythmia 9 9
Pleural Effusion 9 9
Right Ventricular Dysfunction 8 8
Pericardial Effusion 7 7
Tachycardia 6 6
Fatigue 6 6
Hematoma 6 6
Host-Tissue Reaction 6 6
Corneal Pannus 5 5
Pulmonary Embolism 5 5
Abscess 5 5
Cardiac Arrest 5 5
Fever 5 5
Low Blood Pressure/ Hypotension 5 5
Pneumonia 5 5
Myocardial Infarction 5 5
Tricuspid Regurgitation 5 5
Regurgitation 5 5
Heart Failure/Congestive Heart Failure 5 5
Thromboembolism 5 5
Fibrosis 5 5
Heart Block 5 5
Vascular Dissection 4 4
Cusp Tear 4 4
Ventricular Fibrillation 4 4
Aortic Regurgitation 4 4
Aortic Valve Stenosis 4 4
Aortic Insufficiency 3 3
Intimal Dissection 3 3
Bradycardia 3 3
Chest Pain 3 3
Cyanosis 3 3
Pulmonary Edema 3 3
Renal Failure 3 3
Respiratory Distress 3 3
Ventricular Tachycardia 3 3
Rupture 3 3
Cardiogenic Shock 3 3
Unspecified Heart Problem 3 3
Respiratory Insufficiency 3 3
Cardiovascular Insufficiency 2 2
Embolism/Embolus 2 2
No Clinical Signs, Symptoms or Conditions 2 2
Myocardial Hypertrophy 2 2
Valvular Insufficiency/ Regurgitation 2 2
Multiple Organ Failure 2 2
Post Operative Wound Infection 2 2
Cardiac Tamponade 2 2
Tricuspid Valve Stenosis 2 2
Perforation of Vessels 2 2
Vomiting 2 2
Right Ventricular Failure 2 2
Pulmonary Infarction 2 2
Left Ventricular Failure 2 2
Mitral Regurgitation 2 2
Mitral Valve Stenosis 2 2
Occlusion 2 2
Inflammation 2 2
Hemostasis 2 2
Fistula 2 2
Foreign Body Reaction 2 2
Diarrhea 2 2
Congenital Defect/Deformity 2 2
Infarction, Cerebral 2 2
Erosion 2 2
Ossification 2 2
Anemia 2 2
Atrial Fibrillation 2 2

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