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Investigation of this event is pending and a supplemental report will be sent upon its completion.Additional products: heartware ventricular assist system controller 2.0 model #: 1420 / catalog #: 1420 / expiration date: 30-jun-2021 / serial or lot#: (b)(4), udi #: (b)(4) device evaluated: no.No, device evaluation anticipated, but not yet begun mfg date: 30-jun-2020.Labeled for single use: no.(b)(4).If information is provided in the future, a supplemental report will be issued.
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It was reported that the patient was found unresponsive by floor staff while the controller exhibited low flow alarms as well as a no power alarm.It was noted that no power sources were connected to the controller.Power was immediately re-connected and the patient was given cardiopulmonary resuscitation (cpr).The patient then needed to be resuscitated, intubated, and moved to the cardiothoracic intensive care unit (cticu).The patient was then started on inhaled nitric oxide and multiple inotrope drips, and the ventricular assist device (vad) speed was decreased due to suction.The patient coded again and echocardiogram showed very dilated right ventricle (rv) indicating worsening right heart failure.Upon telemetry review, patient was in slow ventricular tachycardia (vt) that lead to ventricular fibrillation (vf) around the time of the controller double disconnect and loss of power.The vad and controller remain in use.No further patient complications have been reported as a result of this event.
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A supplemental report is being submitted for device evaluation product event summary: the pump and controller were not returned for evaluation.Log file analysis revealed that two controller power-up events were logged on (b)(6) 2021 at 13:09:48 and 13:14:30, with one associated motor start event at 13:14:33.Prior to the first power up event, the controller last had power on (b)(6) 2020.Additionally, analysis of the event log file revealed that the date, patient id, pump id, and speed were set between the initial power-up event and the motor start event.Review of the data log file also revealed that the controller was not in use prior to the controller power-up events; the first data point was logged at 13:15:06 on (b)(6) 2021, indicating that these power-up events occurred during a controller exchange.Further log file analysis revealed that another controller power-up event, with an associated motor start event, was logged on (b)(6)2021 at 08:32:08.The data point prior to the loss of power revealed that a power adapter was connected to power port one and battery was connected to power port two with 91% relative state of charge (rsoc).The data point recorded after the loss of power revealed that battery was connected to power port one and a power adapter was connected to power port two.The controller was without power for 3 minutes and 46 seconds.Additionally, twelve low flow alarms were recorded on (b)(6) 2021 between 08:51:08 and 09:38:25.As a result, the reported controller loss of power and low flow events were confirmed.Of note, the suction detection setting was off.As a result, the reported suction event could not be confirmed.Based on the available information, the most likely root cause of the loss of power on (b)(6) 2021 can be attributed to the reported disconnection of both power sources from the controller as described in the event details.The most likely root cause of the loss of power on (b)(6) 2021 can be attributed to a controller exchange.Based on the risk documentation, possible causes of the reported low flow and suction events 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, and/or inappropriate pump rotational speed.Additional information received from the site indicated that, following the controller loss of power, an echocardiogram showed the right ventricle to be very dilated, indicating worsening right heart failure.Additionally, upon telemetry review, the patient was noted to have been in slow ventricular tachycardia that lead to ventricular fibrillation around the time of the controller loss of power on (b)(6) 2021.Per the instructions for use, cardiac arrhythmia and worsening heart failure are known potential complications associated with the implantation of a vad.Based on review of past adverse events for this patient, it was noted that the patient had previously experienced ventricular tachycardia (vt)/ventricular fibrillation (vf) storm.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.Additional products: con412117 h3: yes h6: fda method code(s): b15, b17 h6: fda results code(s): c23 h6: fda conclusion code(s): d11 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.Medtronic is submitting this report to comply with fda reporting regulations under 21 cfr parts 4 and 803.This report is based upon information obtained by medtronic, which the company may not have been able to fully investigate or verify prior to the date the report was required by the fda.Medtronic has made reasonable efforts to obtain more complete information and has provided as much relevant information as is available to the company as of the submission date of this report.This report does not constitute an admission or a conclusion by fda, medtronic, or its employees that the device, medtronic, or its employee caused or contributed to the event described in the report.In particular, this report does not constitute an admission by anyone that the product described in this report has any ¿defects¿ or has ¿malfunctioned¿.These words are included in the fda 3500a form and are fixed items for selection created by the fda to categorize the type of event solely for the purpose of regulatory reporting.Medtronic objects to the use of these words and others like them because of the lack of definition and the connotations implied by these terms.This statement should be included with any information or report disclosed to the public under the freedom of information act.Any required fields that are unpopulated are blank because the information is currently unknown or unavailable.A good faith effort will be made to obtain the applicable information relevant to the report.If information is provided in the future, a supplemental report will be issued.
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