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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)
2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 2019 2020 2021 2022 2023 2024
0 0 0 0 0 0 0 0 0 4 14 5 2 2 3 2

MDR Year MDR Reports MDR Events
2018 14 14
2019 215 215
2020 344 344
2021 405 405
2022 342 342
2023 266 266
2024 29 29

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1487 1487
Material Split, Cut or Torn 78 78
Insufficient Information 44 44
Detachment of Device or Device Component 6 6
Non Reproducible Results 4 4
Unexpected Therapeutic Results 3 3
Appropriate Term/Code Not Available 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 1380 1380
Pneumonia 69 69
No Clinical Signs, Symptoms or Conditions 65 65
Respiratory Failure 55 55
Death 33 33
Cardiac Arrest 29 29
Pleural Effusion 25 25
No Known Impact Or Consequence To Patient 21 21
Respiratory Tract Infection 17 17
Atrial Fibrillation 15 15
Insufficient Information 12 12
Dyspnea 11 11
Hemoptysis 10 10
Sepsis 10 10
Pulmonary Edema 9 9
Pulmonary Emphysema 8 8
Renal Failure 7 7
Low Oxygen Saturation 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
Respiratory Insufficiency 4 4
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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