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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)
2020 2021 2022 2023 2024 2025
5 2 2 3 7 0

MDR Year MDR Reports MDR Events
2020 344 344
2021 405 405
2022 342 342
2023 266 266
2024 176 176
2025 14 14

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 1416 1416
Material Split, Cut or Torn 77 77
Insufficient Information 33 33
Detachment of Device or Device Component 8 8
Non Reproducible Results 4 4
Unexpected Therapeutic Results 3 3
Appropriate Term/Code Not Available 3 3
Lack of Effect 3 3
Off-Label Use 2 2
Use of Device Problem 2 2
Defective Component 2 2
Activation, Positioning or Separation Problem 1 1
Loosening of Implant Not Related to Bone-Ingrowth 1 1
Separation Problem 1 1
Device Contamination with Body Fluid 1 1
No Tactile Prompts/Feedback 1 1
Mechanical Jam 1 1
Gas/Air Leak 1 1
Positioning Failure 1 1
Difficult to Remove 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
Pneumothorax 1279 1279
Pneumonia 76 76
No Clinical Signs, Symptoms or Conditions 75 75
Respiratory Failure 61 61
Cardiac Arrest 37 37
Pleural Effusion 31 31
Respiratory Insufficiency 21 21
Hemoptysis 18 18
Death 18 18
Insufficient Information 17 17
Respiratory Tract Infection 16 16
Atrial Fibrillation 15 15
Dyspnea 12 12
Chronic Obstructive Pulmonary Disease (COPD) 11 11
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available 10 10
Pulmonary Emphysema 10 10
Sepsis 10 10
Pulmonary Edema 9 9
No Known Impact Or Consequence To Patient 9 9
Low Oxygen Saturation 7 7
Renal Failure 7 7
Unspecified Infection 6 6
Adult Respiratory Distress Syndrome 6 6
Patient Problem/Medical Problem 5 5
Hemothorax 5 5
Respiratory Arrest 5 5
Myocardial Infarction 4 4
Obstruction/Occlusion 4 4
Hypoxia 4 4
Fungal Infection 4 4
Septic Shock 4 4
Shock 4 4
Low Blood Pressure/ Hypotension 3 3
Hemorrhage/Bleeding 3 3
Fistula 3 3
Cyst(s) 3 3
Cardiopulmonary Arrest 3 3
Bradycardia 3 3
Ventilator Dependent 3 3
Anemia 3 3
Abscess 3 3
Pulmonary Embolism 3 3
Unspecified Respiratory Problem 3 3
Wheezing 3 3
Unspecified Heart Problem 3 3
Heart Failure/Congestive Heart Failure 3 3
Constipation 3 3
Bronchospasm 3 3
Ischemic Heart Disease 3 3
Chest Pain 2 2

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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