TPLC - Total Product Life Cycle

• Device: one-way air-leak valve
• Definition: To restrict air flow to the target section of the lung. To control prolonged air leaks of the lung, or significant air leaks that are likely to become prolonged air leaks, following lobectomy, segmentectomy, or lung volume reduction surgery (lvrs). An air leak present on post-operative day 7 is considered prolonged unless present only during forced exhalation or cough. An air leak present on day 5 should be considered for treatment if it is: 1) continuous, 2) present during normal inhalation phase of inspiration, or 3) present upon normal expiration and accompanied by subcutaneous emphysema or respiratory compromise.
• Product Code: OAZ
• Device Class: Humanitarian Device Exemption

MDR Year	MDR Reports	MDR Events
2019	2	2
2020	2	2
2021	1	1
2022	5	5
2023	9	9

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	6	6
Off-Label Use	4	4
Migration	4	4
Gas/Air Leak	3	3
Output Problem	1	1
Insufficient Information	1	1
Failure to Eject	1	1
Activation Problem	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Pneumonia	6	6
Pneumothorax	2	2
Hypoxia	2	2
Respiratory Failure	2	2
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available	2	2
No Clinical Signs, Symptoms or Conditions	1	1
Patient Problem/Medical Problem	1	1
Insufficient Information	1	1
Unspecified Infection	1	1
Sepsis	1	1
Ventilator Dependent	1	1
Low Oxygen Saturation	1	1
Bacterial Infection	1	1
Cardiac Arrest	1	1
Death	1	1
Fistula	1	1
Hemoptysis	1	1
Hemorrhage, Cerebral	1	1