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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


Premarket Reviews
ManufacturerDecision
CRYOLIFE, INC.
  SUBSTANTIALLY EQUIVALENT 2

MDR Year MDR Reports MDR Events
2014 10 10
2015 1 1
2016 1 1
2017 6 6
2018 5 5
2019 10 10
2020 12 12
2021 9 9
2022 8 8
2023 15 15
2024 1 1

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 40 40
Insufficient Information 13 13
Appropriate Term/Code Not Available 5 5
Obstruction of Flow 5 5
Device Operates Differently Than Expected 2 2
Material Split, Cut or Torn 2 2
Torn Material 2 2
Restricted Flow rate 2 2
Fracture 2 2
Crack 2 2
Product Quality Problem 2 2
Stretched 1 1
Degraded 1 1
Gradient Increase 1 1
Occlusion Within Device 1 1
Material Puncture/Hole 1 1
Device Contamination with Chemical or Other Material 1 1
Manufacturing, Packaging or Shipping Problem 1 1
Material Integrity Problem 1 1
Backflow 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Endocarditis 10 10
No Code Available 9 9
Insufficient Information 9 9
Stenosis 8 8
No Information 7 7
Pulmonary Valve Stenosis 6 6
Congenital Defect/Deformity 5 5
Bacterial Infection 4 4
Valvular Stenosis 4 4
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Valvular Insufficiency/ Regurgitation 3 3
Unspecified Heart Problem 3 3
Fibrosis 3 3
Pseudoaneurysm 3 3
Calcium Deposits/Calcification 2 2
Death 2 2
Hemorrhage/Bleeding 2 2
Pulmonary Insufficiency 2 2
Ruptured Aneurysm 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Hepatitis 1 1
Herpes 1 1
Low Blood Pressure/ Hypotension 1 1
Failure of Implant 1 1
Insufficiency, Valvular 1 1
Inflammation 1 1
Pulmonary Dysfunction 1 1
Syncope 1 1
Abscess 1 1
Aortic Valve Stenosis 1 1
Stroke/CVA 1 1
Chest Pain 1 1
No Known Impact Or Consequence To Patient 1 1
Post Operative Wound Infection 1 1
Palpitations 1 1
Sudden Cardiac Death 1 1
Abdominal Distention 1 1
Seizures 1 1
Thrombus 1 1
HIV, Human Immunodeficiency Virus 1 1
No Consequences Or Impact To Patient 1 1
Exsanguination 1 1
Fistula 1 1
Fungus 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Artivion, Inc II Apr-16-2024
2 CryoLife, Inc. II Dec-21-2020
3 CryoLife, Inc. II Jun-21-2018
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