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TPLC
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Device
valve, pulmonary
Definition
To improve lung function in patients with emphysema
Product Code
NJK
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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