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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle
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Device valve, pulmonary
Definition To improve lung function in patients with emphysema
Product CodeNJK
Device Class 3

Premarket Approvals (PMA)
2018 2019 2020 2021 2022 2023
4 14 5 2 2 1

MDR Year MDR Reports MDR Events
2018 14 14
2019 215 215
2020 344 344
2021 405 405
2022 342 342
2023 93 93

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1295 1295
Material Split, Cut or Torn 71 71
Insufficient Information 44 44
Non Reproducible Results 4 4
Appropriate Term/Code Not Available 3 3
Unexpected Therapeutic Results 3 3
Detachment of Device or Device Component 3 3
Use of Device Problem 2 2
Defective Component 2 2
Device Contamination with Body Fluid 1 1
Activation, Positioning or Separation Problem 1 1
Device Contamination with Chemical or Other Material 1 1
Gas/Air Leak 1 1
Mechanical Jam 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
No Tactile Prompts/Feedback 1 1
Positioning Failure 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Separation Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pneumothorax 1207 1207
Pneumonia 62 62
No Clinical Signs, Symptoms or Conditions 56 56
Respiratory Failure 49 49
Death 33 33
Cardiac Arrest 25 25
Pleural Effusion 24 24
No Known Impact Or Consequence To Patient 21 21
Respiratory Tract Infection 17 17
Atrial Fibrillation 13 13
Dyspnea 11 11
Sepsis 10 10
Insufficient Information 9 9
Pulmonary Emphysema 8 8
Pulmonary Edema 7 7
Renal Failure 7 7
Low Oxygen Saturation 7 7
Hemoptysis 6 6
Hypoxia 6 6
Adult Respiratory Distress Syndrome 6 6
Abscess 5 5
Patient Problem/Medical Problem 5 5
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 4 4
Respiratory Insufficiency 4 4
Fungal Infection 4 4
Obstruction/Occlusion 4 4
Septic Shock 4 4
Shock 4 4
Unspecified Infection 4 4
Myocardial Infarction 4 4
Ischemic Heart Disease 3 3
Ventilator Dependent 3 3
Anemia 3 3
Cardiopulmonary Arrest 3 3
Bradycardia 3 3
Cyst(s) 3 3
Hemorrhage/Bleeding 3 3
Low Blood Pressure/ Hypotension 3 3
Wheezing 3 3
Unspecified Respiratory Problem 3 3
Bronchospasm 3 3
Constipation 3 3
Unspecified Heart Problem 3 3
Cough 2 2
Foreign Body In Patient 2 2
Chest Pain 2 2
Low Cardiac Output 2 2
Chronic Obstructive Pulmonary Disease (COPD) 1 1
Viral Infection 1 1
Bacterial Infection 1 1
Pulmonary Embolism 1 1
Failure of Implant 1 1
Drug Resistant Bacterial Infection 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Olympus Corporation of the Americas II Feb-01-2022
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