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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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

MDR Year MDR Reports MDR Events
2016 6 6
2017 10 10
2018 6 6
2021 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
Material Separation 2 2
Device Issue 2 2
Break 2 2
Positioning Problem 2 2
Detachment Of Device Component 1 1
Occlusion Within Device 1 1
Inappropriate Waveform 1 1
Difficult to Advance 1 1
Material Integrity Problem 1 1
Physical Resistance 1 1
Patient-Device Incompatibility 1 1
Material Perforation 1 1
Difficult to Remove 1 1
Device Operational Issue 1 1
Device Dislodged or Dislocated 1 1
Human-Device Interface Problem 1 1
Infusion or Flow Problem 1 1
Pumping Problem 1 1
Appropriate Term/Code Not Available 1 1
Device Handling Problem 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
Hypoxia 2 2
Device Embedded In Tissue or Plaque 2 2
Perforation 2 2
No Known Impact Or Consequence To Patient 1 1
Multiple Organ Failure 1 1
Insufficient Information 1 1
No Clinical Signs, Symptoms or Conditions 1 1
Aortic Valve Stenosis 1 1
Calcium Deposits/Calcification 1 1
Cardiopulmonary Arrest 1 1
Hematoma 1 1
Low Blood Pressure/ Hypotension 1 1
Foreign Body In Patient 1 1
Patient Problem/Medical Problem 1 1
Respiratory Distress 1 1
Heart Failure 1 1
Cardiogenic Shock 1 1
Cardiac Perforation 1 1

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