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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)
2019 2020 2021 2022 2023 2024
14 5 2 2 3 3

MDR Year MDR Reports MDR Events
2019 215 215
2020 344 344
2021 405 405
2022 342 342
2023 266 266
2024 53 53

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1494 1494
Material Split, Cut or Torn 82 82
Insufficient Information 44 44
Detachment of Device or Device Component 6 6
Non Reproducible Results 4 4
Appropriate Term/Code Not Available 3 3
Unexpected Therapeutic Results 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
Gas/Air Leak 1 1
Mechanical Jam 1 1
Positioning Failure 1 1
Off-Label Use 1 1
Difficult to Remove 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Migration 1 1
Separation Problem 1 1
No Tactile Prompts/Feedback 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pneumothorax 1379 1379
No Clinical Signs, Symptoms or Conditions 70 70
Pneumonia 69 69
Respiratory Failure 55 55
Death 33 33
Cardiac Arrest 29 29
Pleural Effusion 29 29
No Known Impact Or Consequence To Patient 19 19
Respiratory Tract Infection 17 17
Insufficient Information 16 16
Atrial Fibrillation 15 15
Dyspnea 11 11
Hemoptysis 10 10
Sepsis 10 10
Pulmonary Edema 9 9
Pulmonary Emphysema 8 8
Respiratory Insufficiency 8 8
Low Oxygen Saturation 7 7
Renal Failure 7 7
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 5 5
Unspecified Infection 4 4
Myocardial Infarction 4 4
Septic Shock 4 4
Shock 4 4
Obstruction/Occlusion 4 4
Fungal Infection 4 4
Ventilator Dependent 3 3
Chronic Obstructive Pulmonary Disease (COPD) 3 3
Anemia 3 3
Cardiopulmonary Arrest 3 3
Bradycardia 3 3
Cyst(s) 3 3
Hemorrhage/Bleeding 3 3
Hemothorax 3 3
Low Blood Pressure/ Hypotension 3 3
Wheezing 3 3
Unspecified Respiratory Problem 3 3
Constipation 3 3
Unspecified Heart Problem 3 3
Ischemic Heart Disease 3 3
Bronchospasm 3 3
Foreign Body In Patient 2 2
Low Cardiac Output 2 2
Cough 2 2
Chest Pain 2 2
Bacterial Infection 1 1
Exposure to Body Fluids 1 1
Pulmonary Embolism 1 1
Viral Infection 1 1
Needle Stick/Puncture 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
2 Pulmonx, Corp. II Nov-06-2023
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