This regulatory report is being submitted as part of a retrospective review and remediation per (b)(4) due to an fda audit observation.Product event summary: the ventricular assist device (vad) ((b)(4)) was not returned for evaluation.The reported low flow and suction events were confirmed via review of the controller log files which revealed 2 low flow alarms and 13 suction alarms were logged since (b)(6) 2021.Information provided by the site indicated that the day of the ventricular assist device (vad) implant procedure, the vad exhibited suction and low flow alarms which were attributed to the patient's right ventricular failure.Based on the available information, the device may have caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported suction event and low flow event may be attributed to multiple factors including but not limited to thrombus at the inflow cannula/outflow graft, constriction at the outflow graft, poor vad filling, inappropriate pump rotational speed.Per the instructions for use, right ventricular failure 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.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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It was reported that, the day of the ventricular assist device (vad) implant procedure, the vad exhibited exhibited suction and low flow alarms which were attributed to the patient's right ventricular failure.The vad remains in use.No further patient complications have been reported as a result of this event.
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