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U.S. Department of Health and Human Services

TPLC - Total Product Life Cycle

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Device temporary non-roller type right heart support blood pump
Definition Providing temporary partial or full right heart circulatory support.
Product CodePYX
Regulation Number 870.4360
Device Class 3

Premarket Approvals (PMA)
2019 2020 2021 2022 2023 2024
10 8 8 13 4 1

MDR Year MDR Reports MDR Events
2019 10 10
2020 10 10
2021 7 7
2022 9 9
2023 88 88
2024 101 101

Device Problems MDRs with this Device Problem Events in those MDRs
Adverse Event Without Identified Device or Use Problem 79 79
Improper Flow or Infusion 28 28
Pumping Stopped 27 27
Activation, Positioning or Separation Problem 13 13
Material Twisted/Bent 9 9
Patient-Device Incompatibility 8 8
Restricted Flow rate 8 8
Insufficient Flow or Under Infusion 7 7
Difficult to Advance 7 7
Break 6 6
Increase in Pressure 6 6
Insufficient Information 6 6
Material Split, Cut or Torn 5 5
Failure to Advance 5 5
Material Deformation 5 5
Positioning Problem 4 4
Deformation Due to Compressive Stress 4 4
Failure to Deliver 4 4
Migration 4 4
Physical Resistance/Sticking 3 3
Material Separation 3 3
Pressure Problem 3 3
Infusion or Flow Problem 3 3
Positioning Failure 2 2
Device Sensing Problem 2 2
Crack 2 2
Fluid/Blood Leak 2 2
Material Fragmentation 1 1
Difficult to Insert 1 1
Mechanical Problem 1 1
Failure to Power Up 1 1
Difficult or Delayed Positioning 1 1
Failure to Pump 1 1
Use of Device Problem 1 1
Suction Problem 1 1
Unable to Obtain Readings 1 1
Difficult to Remove 1 1
Inaccurate Delivery 1 1
Defective Component 1 1
Detachment of Device or Device Component 1 1
Connection Problem 1 1
Therapeutic or Diagnostic Output Failure 1 1
Unintended Movement 1 1
No Apparent Adverse Event 1 1
Unexpected Shutdown 1 1
Priming Problem 1 1

Patient Problems MDRs with this Patient Problem Events in those MDRs
No Clinical Signs, Symptoms or Conditions 113 113
Hemolysis 40 40
Hemorrhage/Bleeding 26 26
Thrombosis/Thrombus 19 19
Device Embedded In Tissue or Plaque 6 6
Blood Loss 5 5
Perforation of Vessels 4 4
Hematuria 4 4
Ischemia 4 4
Thrombocytopenia 4 4
Perforation 2 2
Sepsis 2 2
Stroke/CVA 2 2
Vascular Dissection 2 2
Cardiac Tamponade 2 2
Obstruction/Occlusion 1 1
Cardiac Perforation 1 1
Abdominal Distention 1 1
Hypervolemia 1 1
Patient Problem/Medical Problem 1 1
No Known Impact Or Consequence To Patient 1 1
Pericardial Effusion 1 1
Cardiovascular Insufficiency 1 1
Pulmonary Valve Insufficiency/ Regurgitation 1 1
Lactate Dehydrogenase Increased 1 1
Insufficient Information 1 1
Disseminated Intravascular Coagulation (DIC) 1 1
Hematoma 1 1
Hemothorax 1 1
Air Embolism 1 1
Arrhythmia 1 1
Bradycardia 1 1
Cardiac Arrest 1 1
Tachycardia 1 1
Thrombus 1 1
Venipuncture 1 1
Ventricular Fibrillation 1 1
Renal Failure 1 1
Liver Damage/Dysfunction 1 1

Recalls
Manufacturer Recall Class Date Posted
1 Abiomed, Inc. II Jan-04-2024
2 Abiomed, Inc. I Aug-03-2023
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