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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
2021 79 79
2022 67 67
2023 57 57
2024 69 69
2025 41 41
2026 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Insufficient Information 174 174
Patient Device Interaction Problem 49 49
Gradient Increase 39 39
Device Stenosis 35 35
Central Regurgitation 34 34
Calcified 24 24
Adverse Event Without Identified Device or Use Problem 21 21
Degraded 10 10
Inadequacy of Device Shape and/or Size 10 10
Partial Blockage 4 4
Reflux within Device 3 3
Incomplete Coaptation 3 3
Device Markings/Labelling Problem 3 3
Appropriate Term/Code Not Available 3 3
Thickening of Material 3 3
Obstruction of Flow 3 3
Leak/Splash 2 2
Unsealed Device Packaging 2 2
Fracture 2 2
Perivalvular Leak 1 1
Break 1 1
Fluid/Blood Leak 1 1
Expiration Date Error 1 1
Defective Device 1 1
Material Deformation 1 1
Material Integrity Problem 1 1
Mechanics Altered 1 1
Material Split, Cut or Torn 1 1
Material Separation 1 1
Stretched 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 158 158
Pulmonary Valve Stenosis 102 102
Pulmonary Valve Insufficiency/ Regurgitation 87 87
Endocarditis 38 38
Fever 14 14
Non specific EKG/ECG Changes 13 13
Obstruction/Occlusion 12 12
Thrombosis/Thrombus 11 11
Heart Block 11 11
Unspecified Infection 8 8
Calcium Deposits/Calcification 8 8
Tachycardia 6 6
Heart Failure/Congestive Heart Failure 6 6
No Clinical Signs, Symptoms or Conditions 6 6
Hemorrhage/Bleeding 6 6
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 5 5
Sepsis 5 5
Abscess 4 4
Pneumonia 4 4
Aneurysm 4 4
Dyspnea 4 4
Pseudoaneurysm 4 4
Valvular Insufficiency/ Regurgitation 4 4
Embolism/Embolus 4 4
Renal Failure 3 3
Stenosis 3 3
Cardiac Arrest 3 3
Pericardial Effusion 3 3
Thromboembolism 3 3
Irritability 3 3
Stroke/CVA 3 3
Pulmonary Embolism 3 3
Respiratory Insufficiency 2 2
Pulmonary Infarction 2 2
Rupture 2 2
Ventricular Fibrillation 2 2
Myocardial Infarction 2 2
Pleural Effusion 2 2
Diarrhea 2 2
Vomiting 2 2
Unspecified Heart Problem 2 2
Myocardial Hypertrophy 2 2
Arrhythmia 2 2
Mitral Valve Stenosis 1 1
Erosion 1 1
Convulsion/Seizure 1 1
Bacterial Infection 1 1
Headache 1 1
Cardiovascular Insufficiency 1 1
Sore Throat 1 1

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