A supplemental report is being submitted for device evaluation and investigation completion.Product event summary: the ventricular assist device (vad) was returned for evaluation.Various analyses were conducted and reviewed in order to evaluate the performance of the device in relation to the reported event.A review of the pump's manufacturing documentation confirmed that the associated device met all requirements for release.Review of log files was not performed since log files were not available for analysis.Failure analysis of the returned pump revealed that the device passed visual examination and functional testing.Dimensional verification revealed that the front and rear housing disc curvatures were found to be deviating from specifications.Capa pr00578223 was opened to investigate post-explant issues found during failure analysis of returned pumps.Internal pathological report revealed no evidence of thrombus within the device.As a result, the reported event could not be confirmed due to insufficient evidence.Information received from the site indicated that the patient presented to the hospital with an obstruction/ thrombus in ventricular assist device (vad) inflow cannula and the device was explanted.Per the instructions for use, thrombus is a known potential complication associated with the implantation of a vad.Based on the available information, the device may have caused or contributed to the reported event.There was no evidence that the patient had a history of thrombus events.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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