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Model Number 500DM27 |
Device Problem
Incomplete Coaptation (2507)
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Patient Problem
Mitral Valve Insufficiency/ Regurgitation (4451)
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Event Date 05/20/2023 |
Event Type
Injury
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Event Description
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Medtronic received information that during the implant of this 27mm mitral mechanical valve, it was explanted and replaced with a 27mm mechanical valve of a different manufacturer.The reason for the replacement was reported as a leaflet was not coapting properly as it was observed during a final transesophageal echocardiogram (tee) that there was a leak in the center of the valve. a check was performed to determine a possible cause for this but the valve was observed to be properly implanted.It was noted by the physician that "the gap on the coaptation of the leaflets" could not be seen with the naked eye but the central leak could be observed using tee.It was also reported that the valve was rotated within the annulus but the leak still persisted.It was stated that leaflet motion was tested with the blue actuator during the implant procedure.It was mentioned that there was no impingement of the valve leaflets.It was stated that the valve was replaced to ensure patient safety.No additional adverse patient effects were reported. .
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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.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.
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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 appeared discolored showing evidence of blood contact.Both leaflets appeared intact with no evidence of damage such as cracks and/or surface anomalies.Both leaflets were received in the closed position.A blue actuator was used to test leaflet movement, the leaflets moved without difficulty.The orifice appeared intact with no evidence of damage.Both inflow and outflow valve hinge mechanisms appeared intact.The valve was rinsed under tap water, and it was verified that the carbon subassembly rotated in the sewing ring.Conclusion: the investigation is in progress.A supplemental report will be submitted after completion of the investigation.D9: 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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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.
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Search Alerts/Recalls
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