Medtronic received information that post implant of this mitral bioprosthetic valve, as the patient came off pump, central jet regurgitation was observed.It was reported one of the valve leaflets was "relaxed in a bit of a deformed way which could have resulted in the lack of coaptation".The valve was explanted and successfully replaced with a bioprosthetic valve of the same size and model.No additional adverse patient effects were reported. .
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Product analysis: upon receipt at medtronic's quality laboratory, visual examination showed all leaflets were flexible and in a semi-relaxed position which is a standard finding for this valve.An approximately 8mm linear tear was observed on the tunica of the right cusp, possibly occurring during the explant process.Hydrodynamic pulse duplication testing with high speed video observation showed normal, full opening and closing leaflet motion with no evidence of leakage at all flow rates/cardiac outputs.Flow through the valve was documented using echocardiography, digital high speed imaging, and flow meter assessment, and was deemed acceptable.All commissures appeared intact.Conclusion: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.There were no issues or defects observed that could have contributed to the insufficiency.A root cause of the insufficiency could not be established.H6: coding updated.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.
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