|
Model Number 500DM |
Device Problems
Gradient Increase (1270); Perivalvular Leak (1457)
|
Patient Problems
Atrial Fibrillation (1729); Stroke/CVA (1770); Endocarditis (1834); Hemorrhage/Bleeding (1888); Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Valvular Insufficiency/ Regurgitation (4449); Mitral Valve Insufficiency/ Regurgitation (4451)
|
Event Date 08/30/2022 |
Event Type
Injury
|
Event Description
|
Literature was reviewed regarding a comparison of tissue and mechanical valves used during mitral valve replacement.Medtronic (mosaic tissue valves and ats mechanical valves) and non-medtronic (livanova, st.Jude/abbott, cryolife, and edwards lifesciences) valve types were used in the study.The authors stated survival at 3, 5, 7, and 10 years was 94%, 91%, 89%, 86% in the tissue valve group and was 96%, 93%, 91%, 91% in the mechanical valve group, respectively.No evidence was presented to suggest that a medtronic valve or its function contributed to any of the deaths.Other adverse events that occurred were described as follows: continuous renal replacement therapy, dialysis (only needed in the tissue valve group), intra-aortic balloon pump support, extracorporeal membrane oxygenation (ecmo) support, prolonged ventilation (more than 24 hours), bleeding (minor, major, or life-threatening), new atrial fibrillation, rehospitalization for heart failure, rehospitalization for pericardial effusion (one case in the tissue valve group), stroke, thrombosis, endocarditis, mitral valve reoperation, transcatheter valve-in-valve replacement (three cases in the tissue valve group), paravalvular leak, mitral regurgitation, mitral stenosis, and increased mitral valve gradient.No additional adverse patient effects were noted.
|
|
Manufacturer Narrative
|
Citation: arafat aa, et al.Using tissue mitral valves in younger patients: a word of caution.Journal of cardiac surgery.2022 dec; 37(12):4227-4233.Doi: 10.1111/jocs.16881.Epub 2022 aug 30.Earliest date of publication used for date of event.No unique device identifier (serial/lot) numbers were provided; without this information it could not be determined whether these observations have been previously reported.Without return of the product, no definitive conclusion can be made regarding the clinical observations.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.
|
|
Event Description
|
Additional information received from the corresponding physician/author stated, "we can't know if the valves(mosaic tissue valves and ats mechanical valves) caused any adverse events or death.This is a retrospective study and we just report the association." no further information was provided.
|
|
Manufacturer Narrative
|
Additional information received from the corresponding physician/author.See section b5 for the response.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
|
|
|