MEDTRONIC HEART VALVES DIVISION MOSAIC MITRAL BIOPROSTHETIC HEART VALVE; HEART-VALVE, NON-ALLOGRAFT TISSUE
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Model Number 310CJ27 |
Device Problems
Incomplete Coaptation (2507); Material Twisted/Bent (2981)
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Patient Problems
Foreign Body Reaction (1868); Hematoma (1884); Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 12/16/2020 |
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 3 years and 6 months post implant of this 27mm bioprosthetic mitral valve, it was explanted and replaced with a non-medtronic mechanical valve.It was reported that pannus had developed on two of the valve leaflets and one of the valve leaflets was "in a state of retraction", leading to mitral regurgitation.No additional adverse patient effects were reported.
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Manufacturer Narrative
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Medtronic additional information that the mitral regurgitation was severe.No additional adverse patient effects were reported.The product has been returned and analysis is in progress.A supplemental report will be filed upon its completion.B3: event date corrected d6b: explanted date corrected d9: device available for evaluation? updated h3: device evaluated? updated h6: coding updated 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, visual examination revealed that the valve was slightly distorted and oval shaped.All leaflets were flexible except where host tissue extends on the inflow and outflow.Intracuspal hematomas are noted along the inflow margin of attachment of the right and left cusps.Glistening off-white pannus thickly covered and adhered on to the non-coronary cusp appearing to have restricted the leaflet movement.The right and left cusps were in the closed position with the non-coronary cusp open due to infiltrated pannus overgrowth.Due to pannus overgrowth, the condition of the right/non-coronary and left/non-coronary commissures could not be determined.The left/right commissure appeared intact.However, a small amount of pannus was observed on top of their superior coaptive area.Remnants of glistening off-white pannus remained attached along the sewing ring from the outflow and inflow, extending partially into the non-coronary cusp from the inflow.Pannus remains attached to the outflow rail adjacent to the right cusp, extending to and covering the right/non-coronary commissure.Thick off-white pannus filled the non-coronary cusp extending to and partially covering the top of the left/non-coronary commissure.An unknown amount of pannus appears to have been removed during explant.Radiography did not reveal calcification on the returned valve.Conclusions: the device history record was reviewed and showed that this product met all manufacturing specifications for product released for distribution.No issues were identified that would have impacted this event.Pannus is a patient-related condition.Pannus growth in this case had impaired the function of the valve by restricting the leaflet motion, resulting in regurgitation.H3: device evaluated? updated h6: coding updated 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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