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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device heart valve, more than minimally manipulated allograft
Definition For the replacement of diseased, damaged, malformed or malfunctioning native or prosthetic pulmonary heart valves. They may also be used in the replacement of native pulmonary heart valves when the ross procedure is performed. Pulmonary heart valve allografts are used to repair both congential and acquired valvular lesions.
Product CodeOHA
Device Class Unclassified

MDR Year MDR Reports MDR Events
2016 1 1
2017 6 6
2018 5 5
2019 10 10
2020 12 12
2021 4 4

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 21 21
Insufficient Information 7 7
Appropriate Term/Code Not Available 3 3
Obstruction of Flow 3 3
Crack 2 2
Restricted Flow rate 2 2
Material Integrity Problem 1 1
Degraded 1 1
Material Puncture/Hole 1 1
Stretched 1 1
Device Operates Differently Than Expected 1 1
Torn Material 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Code Available 7 7
No Information 6 6
Congenital Defect/Deformity 5 5
Endocarditis 5 5
Pulmonary Valve Stenosis 5 5
Bacterial Infection 4 4
Death 2 2
Valvular Stenosis 2 2
Stenosis 2 2
Pseudoaneurysm 1 1
Pulmonary Dysfunction 1 1
Pulmonary Insufficiency 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Sudden Cardiac Death 1 1
Abdominal Distention 1 1
Aortic Valve Stenosis 1 1
Calcium Deposits/Calcification 1 1
Exsanguination 1 1
Low Blood Pressure/ Hypotension 1 1
Insufficiency, Valvular 1 1

Recalls
Manufacturer Recall Class Date Posted
1 CryoLife, Inc. II Dec-21-2020
2 CryoLife, Inc. II Jun-21-2018
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