Medtronic received information that after the implant procedure for this 28mm mitral mechanical valve, it was explanted and replaced with a valve of the same size and model.The reason for the replacement was reported as the patient had abnormal hemodynamics after the implant procedure. it was reported that an issue with valve leaflet opening and closing was noted on an ultrasound examination.It was stated that a leaflet was stuck.It was noted that after the replacement was performed, the patient's physical signs were normal.It was stated that leaflet motion had been tested with the blue actuator during the implant procedure and the valve had been rotated within the annulus in an attempt to obtain appropriate leaflet motion.The physician did not think it was a case of patient prosthesis mismatch and thought that "the leaflets were not flexible in movement." no additional adverse patient effects were reported.
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Product analysis: no product was returned.Conclusion: without the return of the product, no definitive conclusion can be made regarding the clinical observation.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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