RVAD Both (in the same OR visit) Enter Date of onset of adverse event: in MMDDYYYY format. Select whether patient was or at time of Location of patient: In hospital Out of hospital adverse event. If location was not known, select Unknown. In Hospital Out of Hospital Unknown Please briefly describe this device adverse (malfunction and/or thrombus) including what happened, which component was involved, method of diagnosis, intervention(s) if any, and the result in the text box provided: Thrombus Event If a device malfunction is associated with this thrombus event (suspected or confirmed) please remember to fill out the device malfunction section of this form. Did the patient experience a thrombus event (suspected or confirmed)? If Yes, No, or Unknown yes, then complete the following questions: Was the suspected or confirmed thrombus associated with one or more of the following or symptoms? Select all that apply: Hemolysis (complete the Hemolysis form) Heart Failure Abnormal Pump Parameters Stroke (complete the Neurological Dysfunction Form) TIA (complete the Neurological Dysfunction Form) Arterial Non-CNS Thromboembolism (complete the Arterial Non-CNS Thromboembolism Form) None Other, Specify If specify, then complete the text box. Did the patient have one or more of the following? Select all that apply: Treatment with intravenous anticoagulation (e.g. heparin) Intravenous thrombolytic (e.g. TPA) Intravenous antiplatelet therapy (e.g. eptifibatide) Other, Specify If specify, then complete the text box. Was the thrombus confirmed (see definition below)? Yes, No, or Unknown If yes, then complete the following question: Please select method of confirmation: Select all that apply: Imaging Study
RVAD Both (in the same OR visit) Enter Date of onset of adverse event: in MMDDYYYY format. Location of patient: Select whether patient was In hospital or Out of hospital at time of adverse event. If location was not known, select Unknown. In Hospital Out of Hospital Unknown Please briefly describe this device adverse (malfunction and/or thrombus) including what happened, which component was involved, method of diagnosis, intervention(s) if any, and the result in the text box provided: Thrombus Event If a device malfunction is associated with this thrombus event (suspected or confirmed) please remember to fill out the device malfunction section of this form. Did the patient experience a thrombus event (suspected or confirmed)? Yes, No, or Unknown If yes, then complete the following questions: Was the suspected or confirmed thrombus associated with one or more of the following or symptoms? Select all that apply: Hemolysis (complete the Hemolysis form) Heart Failure Abnormal Pump Parameters Stroke (complete the Neurological Dysfunction Form) TIA (complete the Neurological Dysfunction Form) Arterial Non-CNS Thromboembolism (complete the Arterial Non-CNS Thromboembolism Form) None Other, Specify If specify, then complete the text box. Did the patient have one or more of the following? Select all that apply: Treatment with intravenous anticoagulation (e.g. heparin) Intravenous thrombolytic (e.g. TPA) Intravenous antiplatelet therapy (e.g. eptifibatide) Other, Specify If specify, then complete the text box. Was the thrombus confirmed (see definition below)? Yes, No, or Unknown If yes, then complete the following question: Please select method of confirmation: Select all that apply: Imaging Study
Pedimacs_Users_Guide_v5_0_2018_03_26-1.docx