MEDTRONIC HEART VALVES DIVISION VALVE HANCOCK II AORTIC CINCH 25; HEART-VALVE, NON-ALLOGRAFT TISSUE
|
Back to Search Results |
|
Model Number T505C25 |
Device Problems
Perivalvular Leak (1457); Material Separation (1562); Insufficient Information (3190)
|
Patient Problems
Valvular Insufficiency/ Regurgitation (4449); Insufficient Information (4580)
|
Event Date 07/19/2011 |
Event Type
Injury
|
Event Description
|
Medtronic received information that 1 year and 6 months post implant of this 25mm aortic bioprosthetic valve, it was explanted and replaced with a valve of the same size and model.The reason for the replacement was not reported.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
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.
|
|
Event Description
|
Medtronic received additional information which stated that the reason for replacement was valve dehiscence anteriorly from the annulus and severe aortic insufficiency (ai) with a significant perivalvular leak.It was stated that the dehiscence may be related to the severe degree of calcification which had been encountered during the time of implant of this 25mm valve.It was noted that a cavity of approximately 1.5cm was observed from the anterior annulus towards the right atrium during the replacement procedure.It was stated that cultures taken during the replacement procedure were found to be negative.No additional adverse patient effects were reported.
|
|
Manufacturer Narrative
|
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.
|
|
Search Alerts/Recalls
|
|
|