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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
2014 2 2
2015 25 25
2016 15 15
2017 1 1
2018 2 2
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 24 24
Material Deformation 17 17
Crack 5 5
Appropriate Term/Code Not Available 5 5
Insufficient Information 4 4
Calcified 4 4
Fracture 4 4
Hole In Material 3 3
Obstruction of Flow 2 2
Incomplete Coaptation 1 1
Defective Device 1 1
Device Operates Differently Than Expected 1 1
Improper Device Output 1 1
Gradient Increase 1 1
Naturally Worn 1 1
Leak/Splash 1 1
Occlusion Within Device 1 1
Inadequacy of Device Shape and/or Size 1 1
Failure to Conduct 1 1
Degraded 1 1
Fluid/Blood Leak 1 1
Patient Device Interaction Problem 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Stenosis 19 19
No Code Available 16 16
Death 5 5
Insufficient Information 5 5
Aortic Insufficiency 4 4
Calcium Deposits/Calcification 4 4
Aortic Valve Stenosis 3 3
No Known Impact Or Consequence To Patient 3 3
No Information 3 3
Endocarditis 3 3
Hemorrhage/Bleeding 2 2
Pulmonary Valve Stenosis 2 2
Complaint, Ill-Defined 2 2
Aneurysm 2 2
No Consequences Or Impact To Patient 2 2
Pulmonary Valve Insufficiency/ Regurgitation 2 2
Unspecified Heart Problem 1 1
Cardiac Arrest 1 1
Atrial Fibrillation 1 1
Aortic Regurgitation 1 1
Regurgitation, Valvular 1 1
Obstruction/Occlusion 1 1
Respiratory Failure 1 1
Aortic Dissection 1 1
Blood Loss 1 1
Valvular Insufficiency/ Regurgitation 1 1
Aortic Valve Insufficiency/ Regurgitation 1 1
Renal Failure 1 1
Seizures 1 1
Sepsis 1 1
Tachycardia 1 1
Thrombus 1 1
Ventricular Tachycardia 1 1
Vomiting 1 1
HIV, Human Immunodeficiency Virus 1 1
Hepatitis 1 1
Herpes 1 1
Insufficiency, Valvular 1 1
Unspecified Infection 1 1
Inflammation 1 1
Mitral Valve Stenosis 1 1
Nausea 1 1
Neurological Deficit/Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Feb-11-2011
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