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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device heart-valve, allograft
Product CodeMIE
Device Class 3

MDR Year MDR Reports MDR Events
2019 4 4
2020 3 3
2021 4 4
2022 5 5
2023 4 4
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 14 14
Insufficient Information 2 2
Appropriate Term/Code Not Available 2 2
Calcified 2 2
Obstruction of Flow 2 2
Naturally Worn 1 1
Patient Device Interaction Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Insufficient Information 5 5
Endocarditis 3 3
Stenosis 3 3
Calcium Deposits/Calcification 2 2
Pulmonary Valve Stenosis 2 2
Pulmonary Valve Insufficiency/ Regurgitation 2 2
Unspecified Heart Problem 1 1
Regurgitation, Valvular 1 1
Obstruction/Occlusion 1 1
No Information 1 1
Valvular Insufficiency/ Regurgitation 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Insufficiency, Valvular 1 1
Mitral Valve Stenosis 1 1
Aneurysm 1 1
Aortic Insufficiency 1 1

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