MEDTRONIC HEART VALVE DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 310C31 |
Device Problems
Calcified (1077); Degraded (1153); Material Separation (1562); Biocompatibility (2886); Insufficient Information (3190)
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Patient Problems
Host-Tissue Reaction (1297); Calcium Deposits/Calcification (1758); Mitral Regurgitation (1964); No Information (3190)
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Event Date 11/14/2019 |
Event Type
Injury
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Manufacturer Narrative
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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.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 10 years and 10 months post implant of this mitral bioprosthetic valve, the valve was explanted and replaced with a valve of the same size and model.The reason for the explant was not reported. no additional adverse patient effects were reported. .
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Manufacturer Narrative
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Medtronic received additional information the cause of explant was due to mitral regurgitation.A hospital pathology report received did not report any findings to substantiate the regurgitation.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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Manufacturer Narrative
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Product analysis: upon receipt at medtronic¿s quality laboratory, it was noted that a valve and remnant host tissue were returned.Visual analysis revealed leaflet deterioration on the non-coronary free margin as well as on the right non-coronary commissure.The left and non-coronary cusps were in the closed position, while the right cusp was open towards the right outflow rail.The start of a commissure dehiscence observed on the left-right commissure.The left cusp was prolapsed due to dehiscence of the left non-coronary commissure.The left non-coronary commissure was also dehisced.This appeared to be due to separation of the layers of aortic wall behind the commissure.Traces of pannus were noted along the inflow margin of attachment and sewing ring.An unknown amount of pannus appears to have been removed during explant.Radiography revealed calcification on multiple remnants of the host tissue as well as on all commissural areas.Investigation: since the valve has been implanted for over 10 years, it is very unlikely that the reported regurgitation was due to any potential manufacturing issue.Based on the product analysis, the most likely root cause of the regurgitation would be the commissure dehiscence.Calcification was also present, and calcification is a common cause for commissure dehiscence.Calcification and pannus formation are primarily patient related conditions.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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