TPLC - Total Product Life Cycle

• Device: right ventricular bypass (assist) device
• Definition: To provide circulatory support for patients in cardiogenic shock due to acute right ventricular failure.
• Product Code: OJE
• Device Class: Humanitarian Device Exemption

MDR Year	MDR Reports	MDR Events
2016	6	6
2017	10	10
2018	6	6
2021	2	2
2022	1	1
2023	2	2

Device Problems	MDRs with this Device Problem	Events in those MDRs
Adverse Event Without Identified Device or Use Problem	4	4
Device Operates Differently Than Expected	3	3
Difficult To Position	3	3
Difficult to Remove	2	2
Material Separation	2	2
Device Issue	2	2
Positioning Problem	2	2
Break	2	2
Detachment Of Device Component	1	1
Occlusion Within Device	1	1
Pumping Problem	1	1
Insufficient Information	1	1
Appropriate Term/Code Not Available	1	1
Device Handling Problem	1	1
Device Operational Issue	1	1
Difficult to Advance	1	1
Device Dislodged or Dislocated	1	1
Human-Device Interface Problem	1	1
Infusion or Flow Problem	1	1
Material Integrity Problem	1	1
Inappropriate Waveform	1	1
Physical Resistance	1	1
Patient-Device Incompatibility	1	1
Material Perforation	1	1
Microbial Contamination of Device	1	1

Patient Problems	MDRs with this Patient Problem	Events in those MDRs
Thrombus	6	6
Blood Loss	6	6
Death	3	3
Hemolysis	3	3
Perforation	3	3
Hypoxia	2	2
Device Embedded In Tissue or Plaque	2	2
Hematoma	2	2
Low Blood Pressure/ Hypotension	1	1
Abscess	1	1
Aortic Valve Stenosis	1	1
Calcium Deposits/Calcification	1	1
Cardiopulmonary Arrest	1	1
Foreign Body In Patient	1	1
Patient Problem/Medical Problem	1	1
No Known Impact Or Consequence To Patient	1	1
Heart Failure	1	1
Cardiogenic Shock	1	1
Cardiac Perforation	1	1
Multiple Organ Failure	1	1
Thrombosis/Thrombus	1	1
Retroperitoneal Hemorrhage	1	1
Insufficient Information	1	1
No Clinical Signs, Symptoms or Conditions	1	1
Respiratory Distress	1	1