Study: NCT00121485

Adverse event: Bleeding (All serious events)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: events that cause death, reoperations, permanent injury or necessitate transfusion of \>2 units of PRBC within 24 hours
Frequency: 102 affected / 133 at risk

Adverse event: Bleeding requiring surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 40 affected / 133 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: neurological deficit lasting more than 24 hours or lasting 24 hours or less with a brain imaging study showing new infarction
Frequency: 24 affected / 133 at risk

Adverse event: Other neurological
Serious: yes
Organ System: Nervous system disorders
Notes: any new, temporary or permanent, focal or global neurological deficit including TIA, metabolic encephalopathy, seizure, etc
Frequency: 27 affected / 133 at risk

Adverse event: Local Infection
Serious: yes
Organ System: Infections and infestations
Notes: Localized non-device related infections
Frequency: 40 affected / 133 at risk

Adverse event: Drive Line Infection
Serious: yes
Organ System: Infections and infestations
Notes: infection of the drive line
Frequency: 39 affected / 133 at risk

Adverse event: Pocket Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection of the pump pocket
Frequency: 12 affected / 133 at risk

Adverse event: Pump Housing
Serious: yes
Organ System: Infections and infestations
Notes: Infection of the pump housing
Frequency: 1 affected / 133 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: a systemic response to a serious infection, usually manifested by fever, tachycardia, tachypnea, leukocytosis and vasodilatation requiring use of IV antimicrobial therapy
Frequency: 48 affected / 133 at risk

Adverse event: Right Heart Failure (Inotropes)
Serious: yes
Organ System: Cardiac disorders
Notes: Need for inotropic support for \> 14 days after implant
Frequency: 27 affected / 133 at risk

Adverse event: Right Heart Failure (RVAD)
Serious: yes
Organ System: Cardiac disorders
Notes: the need for RVAD
Frequency: 5 affected / 133 at risk

Adverse event: Peripheral Thromboembolism
Serious: yes
Organ System: Vascular disorders
Notes: Any thrombus or thrombo-embolism in the pulmonary or systemic circulations confirmed by standard clinical and laboratory testing, or operative findings, or autopsy findings, or that requires empirical intervention
Frequency: 14 affected / 133 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Impairment of respiratory function requiring reintubation and/or tracheostomy at any time or the inability to discontinue ventilatory support after 6 days of VAD support
Frequency: 47 affected / 133 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: any arrhythmia that requires intervention
Frequency: 62 affected / 133 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: require renal replacement therapy (CVVHD or dialysis) that was not required prior to implant
Frequency: 21 affected / 133 at risk

Adverse event: Hepatic Dysfunction
Serious: yes
Organ System: Hepatobiliary disorders
Notes: liver function studies that are greater than three times the baseline values in any two of the three liver function studies (total bilirubin, AST and ALT)
Frequency: 3 affected / 133 at risk

Adverse event: Device Thrombosis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: thrombus in device or conduits with symptoms of impaired pump performance (e.g. decreased pump flow, need increase speed, increased power, hemolysis) or need for thrombolytic or surgical intervention
Frequency: 5 affected / 133 at risk

Adverse event: Haemolysis
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: two consecutive PHgb values above 40 mg/dl and a LDH value above 1,000mg/dl during the same time
Frequency: 5 affected / 133 at risk

Adverse event: Psychological
Serious: yes
Organ System: Psychiatric disorders
Notes: disturbance in thinking, emotion or behavior that causes substantial impairment in functioning or marked subjective distress requiring intervention
Frequency: 4 affected / 133 at risk

Adverse event: Confirmed Malfunctions
Serious: yes
Organ System: Cardiac disorders
Frequency: 30 affected / 133 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 16 affected / 133 at risk

Adverse event: Local Infection
Serious: no
Organ System: Infections and infestations
Frequency: 25 affected / 133 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 13 affected / 133 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 133 at risk

Adverse event: Confirmed Malfunctions
Serious: no
Organ System: Cardiac disorders
Frequency: 28 affected / 133 at risk

Adverse event: Bleeding (All serious events)
Serious: yes
Organ System: Blood and lymphatic system disorders
Notes: events that cause death, reoperations, permanent injury or necessitate transfusion of \>2 units of PRBC within 24 hours
Frequency: 41 affected / 59 at risk

Adverse event: Bleeding requiring surgery
Serious: yes
Organ System: Surgical and medical procedures
Frequency: 9 affected / 59 at risk

Adverse event: Cerebrovascular accident
Serious: yes
Organ System: Nervous system disorders
Notes: neurological deficit lasting more than 24 hours or lasting 24 hours or less with a brain imaging study showing new infarction
Frequency: 8 affected / 59 at risk

Adverse event: Other neurological
Serious: yes
Organ System: Nervous system disorders
Notes: any new, temporary or permanent, focal or global neurological deficit including TIA, metabolic encephalopathy, seizure, etc
Frequency: 9 affected / 59 at risk

Adverse event: Local Infection
Serious: yes
Organ System: Infections and infestations
Notes: Localized non-device related infections
Frequency: 19 affected / 59 at risk

Adverse event: Drive Line Infection
Serious: yes
Organ System: Infections and infestations
Notes: infection of the drive line
Frequency: 14 affected / 59 at risk

Adverse event: Pocket Infection
Serious: yes
Organ System: Infections and infestations
Notes: Infection of the pump pocket
Frequency: 8 affected / 59 at risk

Adverse event: Pump Housing
Serious: yes
Organ System: Infections and infestations
Notes: Infection of the pump housing
Frequency: 2 affected / 59 at risk

Adverse event: Sepsis
Serious: yes
Organ System: Infections and infestations
Notes: a systemic response to a serious infection, usually manifested by fever, tachycardia, tachypnea, leukocytosis and vasodilatation requiring use of IV antimicrobial therapy
Frequency: 26 affected / 59 at risk

Adverse event: Right Heart Failure (Inotropes)
Serious: yes
Organ System: Cardiac disorders
Notes: Need for inotropic support for \> 14 days after implant
Frequency: 16 affected / 59 at risk

Adverse event: Right Heart Failure (RVAD)
Serious: yes
Organ System: Cardiac disorders
Notes: the need for RVAD
Frequency: 3 affected / 59 at risk

Adverse event: Peripheral Thromboembolism
Serious: yes
Organ System: Vascular disorders
Notes: Any thrombus or thrombo-embolism in the pulmonary or systemic circulations confirmed by standard clinical and laboratory testing, or operative findings, or autopsy findings, or that requires empirical intervention
Frequency: 6 affected / 59 at risk

Adverse event: Respiratory failure
Serious: yes
Organ System: Respiratory, thoracic and mediastinal disorders
Notes: Impairment of respiratory function requiring reintubation and/or tracheostomy at any time or the inability to discontinue ventilatory support after 6 days of VAD support
Frequency: 24 affected / 59 at risk

Adverse event: Arrhythmia
Serious: yes
Organ System: Cardiac disorders
Notes: any arrhythmia that requires intervention
Frequency: 21 affected / 59 at risk

Adverse event: Renal failure
Serious: yes
Organ System: Renal and urinary disorders
Notes: require renal replacement therapy (CVVHD or dialysis) that was not required prior to implant
Frequency: 14 affected / 59 at risk

Adverse event: Myocardial infarction
Serious: yes
Organ System: Cardiac disorders
Frequency: 1 affected / 59 at risk

Adverse event: Confirmed Malfunctions
Serious: yes
Organ System: Cardiac disorders
Frequency: 12 affected / 59 at risk

Adverse event: Haemorrhage
Serious: no
Organ System: Blood and lymphatic system disorders
Frequency: 10 affected / 59 at risk

Adverse event: Local Infection
Serious: no
Organ System: Infections and infestations
Frequency: 8 affected / 59 at risk

Adverse event: Arrhythmia
Serious: no
Organ System: Cardiac disorders
Frequency: 14 affected / 59 at risk

Adverse event: Psychological
Serious: no
Organ System: Psychiatric disorders
Frequency: 4 affected / 59 at risk

Adverse event: Confirmed Malfunctions
Serious: no
Organ System: Cardiac disorders
Frequency: 6 affected / 59 at risk