It was reported that the patient was hospitalized for an arterial non-central nervous system (cns) thromboembolism, an unspecified neurological dysfunction that was diagnosed with computerized tomography (ct), and hemolysis.The thrombus was confirmed via imaging study.The ventricular assist device (vad) was decommissioned due to thrombus.The ventricular assist device (vad) remains in patient.No further patient complications have been reported as a result of this event.This event was reported in the q4 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
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Product event summary: a pump with unknown serial number was not returned for evaluation.Review of the controller log files could not be conducted since log files were not available.As a result, the reported thrombus event could not be confirmed.Based on the limited information available, the device may have caused or contributed to the reported event.Per the instructions for use, this event is a known potential complication associated with the implantation of a vad.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, the progression of their underlying disease, issues related to the therapeutic use of anticoagulant and antiplatelet medications and the patient's complex post-operative course.There are possible patient, pharmacological and procedural factors that may have contributed to this event.This event was reported in the q4 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.Investigation of this event is completed and the file will be closed.If new information is received, the file will be re-opened and a supplemental will be submitted.If information is provided in the future, a supplemental report will be issued.
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