TPLC - Total Product Life Cycle

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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)
2021	2022	2023	2024	2025	2026
2	2	3	7	0	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	1264	1266
Material Split, Cut or Torn	79	79
Insufficient Information	23	23
Migration	8	8
Detachment of Device or Device Component	6	6
Non Reproducible Results	4	4
Difficult to Remove	4	4
Lack of Effect	3	3
Appropriate Term/Code Not Available	3	3
Unexpected Therapeutic Results	3	3
Off-Label Use	2	2
Defective Component	2	2
Use of Device Problem	2	2
Separation Problem	1	1
Device Contamination with Body Fluid	1	1
Device Damaged Prior to Use	1	1
Defective Device	1	1
Material Integrity Problem	1	1
Loosening of Implant Not Related to Bone-Ingrowth	1	1
Positioning Failure	1	1
Material Separation	1	1
Activation Failure	1	1
No Tactile Prompts/Feedback	1	1
Difficult to Open or Close	1	1
Firing Problem	1	1
Mechanical Jam	1	1
Premature Activation	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pneumothorax	1099	1099
No Clinical Signs, Symptoms or Conditions	97	97
Pneumonia	90	90
Respiratory Failure	73	73
Cardiac Arrest	37	37
Dyspnea	32	32
Hemoptysis	30	30
Chronic Obstructive Pulmonary Disease (COPD)	30	30
Respiratory Insufficiency	29	29
Pleural Effusion	24	24
Insufficient Information	21	21
Atrial Fibrillation	16	16
Respiratory Tract Infection	16	16
Sepsis	15	15
Unspecified Infection	12	12
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	12	12
Hemothorax	11	11
Loss of consciousness	9	9
Pulmonary Emphysema	9	9
Pulmonary Embolism	8	8
Renal Failure	7	7
Chest Pain	7	7
Cough	6	6
Respiratory Arrest	5	5
Respiratory Acidosis	5	5
Myocardial Infarction	4	4
Tachycardia	4	4
Shock	4	4
Septic Shock	4	4
Fever	4	4
Obstruction/Occlusion	4	4
Wheezing	4	4
Fungal Infection	4	4
Patient Problem/Medical Problem	4	4
Renal Impairment	3	3
Abscess	3	3
Bradycardia	3	3
Heart Failure/Congestive Heart Failure	3	3
Anemia	3	3
Ischemic Heart Disease	3	3
Cyst(s)	3	3
Bronchospasm	3	3
Hypoxia	3	3
Unspecified Heart Problem	3	3
Hemorrhage/Bleeding	3	3
Constipation	3	3
Adult Respiratory Distress Syndrome	3	3
Low Blood Pressure/ Hypotension	3	3
Ventilator Dependent	3	3
Low Oxygen Saturation	3	3

Recalls
Manufacturer		Recall Class	Date Posted
1	Olympus Corporation of the Americas	II	Feb-01-2022
2	Pulmonx, Corp.	II	Nov-06-2023