This regulatory report is being submitted as part of a retrospective review and remediation per d00700870.This information was received from the mechanical circulatory support product surveillance registry study.Product event summary: hw36514 was not returned for evaluation.The reported low flow event could not be confirmed as log files covering the reported event date were not available for analysis.Information received from the site indicated that, in addition to low flows, the patient experienced ventricular tachycardia (vt) with recurrent palpitations and some dizzy spells; the patient was given oral medication.Based on the limited information available, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow event may be attributed to multiple factors including but not limited to poor vad filling, thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, and/or inappropriate pump rotational speed.Per the instructions for use, cardiac arrhythmia is a known potential complication associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had a history of vt.Possible clinical factors that may have contributed to this event include the patient¿s pre-existing history and related comorbidities, 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.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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