Medtronic received information that seven years, six months, one day following the implant of this transcatheter bioprosthetic pulmonary valve, for an unknown reason, the valve was explanted and replaced with a different pulmonary valve.No additional adverse patient effects were reported.
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Updated data: the age of the patient and length of valve implant reasonably suggest that the reason for replacement is patient outgrowth; therefore, the event does not meet reporting criteria.Melody ifu: clinical consideration regarding the device lifetime from the ifu: the melody¿ tpv is used in the palliative treatment of rvot conduit or bioprosthetic valve dysfunction with a goal of delaying the next surgical intervention.Some patients will require valve reintervention or replacement, the timing of which is dependent on several factors.H6.Device code.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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