Product event summary: a pump with unknown serial number was not returned for evaluation.This complaint is associated with a clinical adverse event.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.
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It was reported that the patient was hospitalized for unspecified trauma or accident, hemolysis and an unspecified neurological dysfunction that was diagnosed with computerized tomography (ct).A renal arterial non central nervous system (cns) thromboembolism was diagnosed via standard clinical, laboratory testing and imaging study.The ventricular assist device (vad) remains in use.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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