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This device is used for treatment not diagnosis.The ventricular assist system is indicated for use as a bridge to cardiac trans plantation and destination therapy in patients who are at risk of death from refractory end-stage left ventricular heart failure.The system is designed for in-hospital and out-of-hospital settings.Medtronic was made aware of this event through a search of literature publications.It was not possible to ascertain specific device information from the literature publication or to match the event with previously reported events.This information is based entirely on journal literature.All information provided is included in this report.Patient information is limited due to confidentiality concerns.Without a lot number or device serial number, the manufacturing date cannot be determined.Since no device id was provided, it is unknown if this event has been previously reported.Request for additional information will be made and upon receipt a supplemental report will be submitted accordingly.Referenced article: transcatheter aortic valve replacement thrombosis in patient supported with durable left ventricular assist device.Catheterization and cardiovascular interventions (united states), august 2020; 96(2):500-503.Additional information has been requested regarding the cause of the event, but it was not available at the time of this report.If additional information is received, the event will be updated and a supplemental report will be sent.Investigation of this event is pending and a supplemental report will be sent upon its completion.If information is provided in the future, a supplemental report will be issued.
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A journal article was reviewed which contained information regarding ventricular assist devices (vads).The article was a case report regarding thrombosis on a prosthetic aortic valve in a patient using a vad for left ventricular support.One patient's post-operative course on left vad (lvad) support was complicated by gastrointestinal bleeding (gib), requiring two hospital admissions for blood transfusions and changes to the anticoagulation regimen.The patient later developed progressively severe aortic insufficiency with worsening heart failure symptoms six months post-implantation.The patient underwent transcatheter aortic valve replacement (tavr) and was later discharged from the hospital.Over the next three months, the pump exhibited low flow alarms, despite adjustments to medication and lvad speed.The patient later developed further gastrointestinal bleeding receiving increased anticoagulation medication while hospitalized to treat prosthetic aortic valve thrombosis.Multiple blood transfusions were required as treatment.Lvad speed was increased to minimize aortic valve opening in the setting of valve thrombosis, however this resulted in recurrent suction events.The vad remains 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 investigation completion.Product event summary: one pump with unknown serial number was not returned for evaluation.Log file analysis could not be performed since log files covering the reported event date were not available for analysis.As a result, the reported low flow/ suction event could not be confirmed.Based on the investigation conducted, there is no evidence to suggest that a device malfunction caused or contributed to the reported event.Based on the risk documentation, possible causes of the reported low flow/ suction 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.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.### 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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