Model Number 310C25 |
Device Problems
Perivalvular Leak (1457); Patient Device Interaction Problem (4001); Device Stenosis (4066); Central Regurgitation (4068)
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Patient Problems
Mitral Valve Stenosis (1965); Thrombosis/Thrombus (4440); Valvular Insufficiency/ Regurgitation (4449)
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Event Date 06/12/2023 |
Event Type
Injury
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Manufacturer Narrative
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Product analysis: the device remains implanted, therefore no product analysis can be performed.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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Event Description
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Medtronic received information that 16 years and 3 months post implant of this 25mm mitral bioprosthetic valve, the patient is being evaluated for a for a potential replacement.During the evaluation it was reported that the transesophageal echocardiography (tee) showed an enlarged right ventricle, right ventricular systolic function normal, left atrium is moderately to severely dilated, mitral valve ring dehiscence and perforation of anterior and posterior valve leaflets, ruptured cords, severe mitral regurgitation (mr), mean mitral valve gradient of 6.4mmhg, mitral stenosis(ms), left atrial appendage has been sutured, with doppler evidence of flow at the edges of the sutures and a thrombus seen in the left atrium.No intervention or adverse patient effects were reported.
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Search Alerts/Recalls
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